This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM) (NCT00555399), a randomized phase 1, phase 2 study. The primary outcome is Maximum Tolerated Dose (MTD).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00555399 |
| Phase | Phase 1, Phase 2 |
| Condition | Glioblastoma Multiforme, Anaplastic Glioma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 55 |
| Arms in the primary outcome | 4 |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Adults with recurrent glioblastoma multiforme or anaplastic gliomas were the stated population. The registry record reports 55 enrolled participants and says that 52 were evaluable for the primary outcome. Two participants withdrew consent, and one chose not to proceed with treatment.
Intervention
The Phase I arm descriptions include vorinostat plus isotretinoin, temozolomide plus isotretinoin, and vorinostat plus isotretinoin plus temozolomide. The trial also included Phase II non-surgical and surgical arms. The primary outcome description instead names vorinostat plus isotretinoin, carboplatin plus isotretinoin, and a vorinostat, isotretinoin, and carboplatin combination.
Comparator
The study is described as randomized, unmasked, and parallel. The posted primary outcome is a dose-finding measure rather than a treatment-effect comparison between two arms. A specific pairwise comparator for the primary result is not reported in the registry record.
Primary question
The primary question was which cohort number corresponded to the maximum tolerated dose for each listed combination. The outcome entries give cohort numbers for Arm 1, Arm 2, Arm 3A, and Arm 3B. They do not give a comparative estimate of tumor control or a statistical test of differences between arms.
The trial’s brief summary describes an interest in whether vorinostat, given with isotretinoin and temozolomide, could help control glioblastoma or gliosarcoma, with safety also to be studied. However, the posted primary result concerns maximum tolerated dose, not tumor-control efficacy. The registry record does not post an efficacy comparison or an estimate of treatment effect. Interpretation should therefore stay focused on the dose-finding outcome and the safety counts, while recognizing the difference between the brief summary and the primary endpoint.
3. Trial Design
The record identifies a Phase I / II randomized trial with parallel groups and no masking. It lists 55 enrolled participants and the conditions glioblastoma multiforme and anaplastic glioma. The sponsor is M.D. Anderson Cancer Center. The listed start date is 2007-11-28, the primary completion date is 2020-01-24, and the current status is terminated. The reason for termination is not reported in the registry record.
Phase I arm descriptions list vorinostat plus isotretinoin, temozolomide plus isotretinoin, and the three-drug combination of vorinostat, isotretinoin, and temozolomide. Phase II arm descriptions distinguish a non-surgical arm and a surgical arm. The record lists surgical resection as an intervention. It does not report the assignment procedure, allocation ratio, stratification factors, or how the adaptive feature operated. Those details should not be inferred from the trial title or the word “adaptive.”
The primary outcome is a maximum tolerated dose measure expressed as the cohort number at which the maximum tolerated dose was declared. Its stated timeframe is 62 months. The outcome description names combinations involving carboplatin, whereas the listed interventions and Phase I arm descriptions name temozolomide. The record does not explain this difference. The primary outcome population states that 52 of the 55 enrolled participants were evaluable; two withdrew consent and one chose not to proceed with treatment. The group-specific outcome entries list 12 participants for Arm 1, 12 for Arm 2, 19 for Arm 3A, and 9 for Arm 3B.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Only the first 6 of 12 groups are shown.
Overall Study
| Stage | Arm 1 Cohort 1 | Arm 1 Cohort 2 | Arm 1 Cohort 3 | Arm 2 Cohort 1 | Arm 2 Cohort 2 | Arm 2 Cohort 3 |
|---|---|---|---|---|---|---|
| STARTED | 3 | 3 | 8 | 6 | 3 | 3 |
| COMPLETED | 3 | 3 | 6 | 6 | 3 | 3 |
| NOT COMPLETED | 0 | 0 | 2 | 0 | 0 | 0 |
Reasons for not completing this period:
| Reason | Arm 1 Cohort 1 | Arm 1 Cohort 2 | Arm 1 Cohort 3 | Arm 2 Cohort 1 | Arm 2 Cohort 2 | Arm 2 Cohort 3 |
|---|---|---|---|---|---|---|
| Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 |
| Patient decided not to proceed with treatment | 0 | 0 | 1 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: 52 out of 55 enrolled participants were evaluable. Two patients withdrew consents, and one patient chose not to proceed with treatment.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Data provided for the demographics of participants enrolled into each arm is not related to the treatment cohorts but to the combination of agents used.
Only the first 6 of 13 groups are shown.
| Characteristic | Unit | Arm 1 Cohort 1 | Arm 1 Cohort 2 | Arm 1 Cohort 3 | Arm 2 Cohort 1 | Arm 2 Cohort 2 | Arm 2 Cohort 3 |
|---|---|---|---|---|---|---|---|
| Participants analysed | 3 | 3 | 8 | 6 | 3 | 3 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 3 | 3 | 5 | 6 | 3 | 3 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 3 | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 2 | 0 | 2 | 4 | 1 | 2 |
| Sex: Female, Male: Male | Participants | 1 | 3 | 6 | 2 | 2 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 1 | 1 | 0 |
| Race (NIH/OMB): White | Participants | 2 | 2 | 6 | 5 | 1 | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 1 | 2 | 0 | 1 | 0 |
| Region of Enrollment: United States | participants | 3 | 3 | 8 | 6 | 3 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Tolerated Dose (MTD), measured over 62 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | cohort number |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the maximum tolerated dose, reported not as a dose amount but as the cohort number at which the maximum tolerated dose was declared for each arm. A cohort number identifies a stage in the dose-finding sequence; it does not itself tell the reader the dose in mg/day or AUC. The outcome description says doses were measured in mg/day for vorinostat and isotretinoin, or AUC for carboplatin, but the posted endpoint values are cohort numbers rather than those dose amounts.
In general, dose-finding studies use a maximum tolerated dose endpoint to identify a dose level for further study while examining tolerability. The cohort number is useful for describing where that dose decision occurred in the sequence, but it is not a measure of tumor response, survival, or comparative efficacy. Nor does the cohort number alone describe the frequency or severity of adverse events at every dose level.
The outcome entries report cohort number 2 for Arm 1, cohort number 2 for Arm 2, cohort number 4 for Arm 3A, and cohort number 2 for Arm 3B. The specific numeric dose corresponding to each result and the decision criteria used to declare the maximum tolerated dose are not reported in the registry record. There is also a terminology inconsistency: the primary endpoint description refers to carboplatin combinations, while the intervention list and Phase I arm descriptions refer to temozolomide combinations. The registry record does not reconcile these descriptions.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results are dose-finding outcomes. They place the maximum tolerated dose declaration at cohort number 2 for Arm 1, cohort number 2 for Arm 2, cohort number 4 for Arm 3A, and cohort number 2 for Arm 3B. These are descriptive results for the listed arms, not estimates of how much one treatment changes an outcome relative to another. The cohort-number scale should not be read as a direct dose scale: actual dose values are not posted with these results.
The registry identifies the study as randomized, but the primary result is not presented as a randomized comparison. The posted analysis count is zero, and no treatment-effect estimates, confidence intervals, or p-values are reported in the registry record. That means the cohort-number results do not establish whether one regimen is better or worse than another for tumor control, survival, or any other efficacy outcome. The brief summary describes an interest in disease control, but the posted primary outcome does not report that question’s result.
The endpoint description and intervention descriptions also differ in the third drug named: the outcome description refers to carboplatin, while the intervention and Phase I arm descriptions refer to temozolomide. This leaves uncertainty about how to map the named combinations in the endpoint description to the named trial arms. The record gives no clarification, so the cohort outcomes should be presented using the arm labels and endpoint values as posted rather than resolving the discrepancy by assumption.
The primary population statement says 52 of 55 enrolled participants were evaluable, with two consent withdrawals and one participant who did not proceed with treatment. The arm entries also provide group sizes. These figures describe enrollment and outcome populations, but the registry does not explain in detail how evaluability was defined or whether all enrolled participants were included in every safety or outcome analysis.
Safety information is posted separately as counts by arm and cohort. Serious adverse events were recorded in some cohort listings, and the record names pulmonary embolism and death among the leading serious-event terms. These counts provide descriptive context, but there is no posted inferential comparison of safety between regimens. The trial status is terminated; the reason is not reported in the registry record. Overall, the results support a limited reading about the cohort numbers associated with the stated dose-finding endpoint and the posted adverse-event counts, not a conclusion about efficacy or comparative safety.
9. Statistical Methods Explained
The registry describes a randomized, unmasked, parallel Phase I / II study. Those labels describe broad features of the design: participants were assigned at random, masking was absent, and the study used parallel groups. They do not by themselves specify the assignment process, allocation ratio, or the statistical methods used for the endpoint. Those details are not reported in the registry record. The word “adaptive” appears in the official title, but the record does not describe any adaptation rules or how they affected enrollment, dose assignment, or analysis.
What does a cohort-number endpoint mean?
In general, dose-finding studies can examine successive cohorts receiving dose levels or regimens and use safety observations to guide dose decisions. A maximum tolerated dose is a dose-finding target, not an efficacy estimate. Here, the endpoint is recorded as the cohort number at which the maximum tolerated dose was declared. The posted values are cohort numbers; they are not the dose amounts themselves. The record describes dose units as mg/day for vorinostat and isotretinoin, or AUC for carboplatin, but does not post the dose associated with each cohort result.
The reported cohort number also does not reveal, on its own, the rule that defined a maximum tolerated dose. Decision thresholds, dose-escalation rules, cohort expansion criteria, and dose-limiting toxicity definitions are not reported in the registry record. Without those details, readers can describe where the endpoint was declared according to the posted cohort numbering, but cannot reconstruct the decision process from the outcome values alone.
How should the arm results be read?
The outcome entries give a cohort number for each of four labels: Arm 1, Arm 2, Arm 3A, and Arm 3B. These are not paired estimates from a single two-arm contrast. The registry’s outcome classification says that the endpoint is not reduced to one comparison, and no analyses are posted. A direct comparison of these cohort values would require caution because the record does not explain whether arms shared a dose sequence, used the same escalation rules, or represented comparable treatment combinations.
General statistical interpretation distinguishes a descriptive endpoint from a comparative estimate. A comparative estimate would quantify a difference between defined groups and usually include uncertainty information. The registry does not report such an estimate for this primary outcome. It also does not report confidence intervals, p-values, or model-based results. No treatment-effect claim can be derived from the four cohort numbers alone.
What do the safety counts contribute?
The registry lists serious adverse-event counts and other adverse-event counts for each arm and cohort. In general, event counts summarize what was recorded in the specified groups; they do not automatically provide a risk comparison. To interpret a comparative safety effect, readers need clear denominators, consistent follow-up, event definitions, and an analysis plan. The record includes counts at risk for the listed adverse-event groups, but does not describe the event collection or follow-up procedures in detail. It does not post a statistical comparison of adverse events between arms.
General concepts such as confidence intervals and over-dispersion are not directly used in the posted results. A confidence interval describes the uncertainty around an estimate; there is no interval estimate posted for the cohort-number endpoint. Over-dispersion is relevant when count data vary more than a chosen statistical model expects, but the registry record does not report a count model or an analysis requiring that assessment. These concepts should not be mistaken for methods used in this trial.
The record lists 55 enrolled participants and says that 52 were evaluable for the primary endpoint. The outcome arm entries give group sizes, but the record does not provide a detailed flow of participants through each phase, cohort, or analysis population. The reasons given for non-evaluability are two consent withdrawals and one participant who chose not to proceed with treatment. The definitions and handling of missing endpoint data beyond these statements are not reported in the registry record.
The primary outcome description names carboplatin combinations, while the intervention list and Phase I arm descriptions name temozolomide. This discrepancy complicates interpretation of exactly which combinations correspond to the endpoint. No statistical technique can resolve a mismatch in the recorded treatment descriptions without clarification from the trial record. The most transparent approach is to retain the posted arm labels and report the discrepancy explicitly.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a Phase I / II study with several arm descriptions and more than one outcome measure, but it posts no statistical analyses. The number of analyses reported is zero, and there are no secondary outcomes posted. Consequently, there is no documented set of hypothesis tests or confidence intervals from which to assess multiplicity adjustments. Whether the protocol specified a correction, hierarchical testing, or another approach is not reported in the registry record.
In general, multiplicity arises when a study makes several statistical comparisons or evaluates multiple outcomes. Without the analysis plan and posted tests, it is not possible to determine whether multiplicity was addressed or whether it affected interpretation. The posted maximum tolerated dose cohort numbers are descriptive values, not a family of reported treatment-effect tests.
For the primary endpoint population, the record says that 52 out of 55 enrolled participants were evaluable. It identifies two participants who withdrew consent and one who chose not to proceed with treatment. The record does not report how missing endpoint information was handled beyond describing these participants, nor does it state whether an intention-to-treat population was used. The meaning of “evaluable” is not defined in the registry record.
The adverse-event listings show counts by arm and cohort, but the record does not provide further details about safety follow-up, missing safety observations, or an analysis population for those counts. No imputation method or sensitivity analysis is reported. These omissions limit assessment of how incomplete observations might affect the outcome summaries.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Arm 1 Cohort 1 | 0 | 3 | 0.0% |
| Arm 1 Cohort 2 | 1 | 3 | 33.3% |
| Arm 1 Cohort 3 | 0 | 8 | 0.0% |
| Arm 2 Cohort 1 | 0 | 6 | 0.0% |
| Arm 2 Cohort 2 | 0 | 3 | 0.0% |
| Arm 2 Cohort 3 | 0 | 3 | 0.0% |
| Arm 3A Cohort 1 | 0 | 5 | 0.0% |
| Arm 3A Cohort 2 | 1 | 6 | 16.7% |
| Arm 3A Cohort 3 | 0 | 5 | 0.0% |
| Arm 3A Cohort 4 | 0 | 3 | 0.0% |
| Arm 3B Cohort 1 | 0 | 3 | 0.0% |
| Arm 3B Cohort 2 | 1 | 7 | 14.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm 1 Cohort 1 | 0 of 3 |
| Arm 1 Cohort 2 | 0 of 3 |
| Arm 1 Cohort 3 | 0 of 8 |
| Arm 2 Cohort 1 | 0 of 6 |
| Arm 2 Cohort 2 | 0 of 3 |
| Arm 2 Cohort 3 | 0 of 3 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Arm 1 Cohort 1 | 3 of 3 |
| Arm 1 Cohort 2 | 3 of 3 |
| Arm 1 Cohort 3 | 8 of 8 |
| Arm 2 Cohort 1 | 6 of 6 |
| Arm 2 Cohort 2 | 3 of 3 |
| Arm 2 Cohort 3 | 3 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm 1 Cohort 1 | Arm 1 Cohort 2 | Arm 1 Cohort 3 | Arm 2 Cohort 1 | Arm 2 Cohort 2 | Arm 2 Cohort 3 |
|---|---|---|---|---|---|---|---|
| Pulmonary Embolism | Vascular disorders | 0 of 3 | 1 of 3 | 0 of 8 | 0 of 6 | 0 of 3 | 0 of 3 |
| Death | General disorders | 0 of 3 | 0 of 3 | 0 of 8 | 0 of 6 | 0 of 3 | 0 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm 1 Cohort 1 | Arm 1 Cohort 2 | Arm 1 Cohort 3 | Arm 2 Cohort 1 | Arm 2 Cohort 2 | Arm 2 Cohort 3 |
|---|---|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | 3 of 3 | 3 of 3 | 6 of 8 | 2 of 6 | 3 of 3 | 3 of 3 |
| Fatigue | Nervous system disorders | 3 of 3 | 2 of 3 | 4 of 8 | 4 of 6 | 3 of 3 | 3 of 3 |
| Cholesterol Elevated | Cardiac disorders | 2 of 3 | 2 of 3 | 5 of 8 | 6 of 6 | 1 of 3 | 2 of 3 |
| Dry Skin | Skin and subcutaneous tissue disorders | 3 of 3 | 1 of 3 | 3 of 8 | 5 of 6 | 2 of 3 | 1 of 3 |
| Platelets count decreased | Blood and lymphatic system disorders | 1 of 3 | 1 of 3 | 5 of 8 | 3 of 6 | 2 of 3 | 2 of 3 |
| Nausea | Gastrointestinal disorders | 1 of 3 | 1 of 3 | 3 of 8 | 4 of 6 | 1 of 3 | 2 of 3 |
| Anorexia | Gastrointestinal disorders | 1 of 3 | 0 of 3 | 4 of 8 | 2 of 6 | 2 of 3 | 0 of 3 |
| Insomnia | Nervous system disorders | 2 of 3 | 1 of 3 | 2 of 8 | 3 of 6 | 1 of 3 | 0 of 3 |
| ALT elevated | Metabolism and nutrition disorders | 0 of 3 | 2 of 3 | 2 of 8 | 1 of 6 | 1 of 3 | 2 of 3 |
| Dyspnea | Cardiac disorders | 2 of 3 | 1 of 3 | 1 of 8 | 1 of 6 | 1 of 3 | 1 of 3 |
Serious events with the highest arm-level rate: pulmonary embolism (33.3%), death (16.7%).
The adverse-event information is organized by arm and cohort, with counts at risk, counts affected by serious events, counts affected by other events, and deaths. Serious adverse events are listed for Arm 1 Cohort 2, Arm 3A Cohort 2, and Arm 3B Cohort 2; the other cohort entries show zero serious events. The posted death counts are 1 for Arm 3A Cohort 2 and 1 for Arm 3B Cohort 2, with zero in the other listed cohorts. These are group-level descriptions, not comparisons adjusted for differences in group size or follow-up.
The leading serious-event terms listed are pulmonary embolism at 33.3% and death at 16.7%. The registry does not explain the denominator used for these percentages in the posted information, so they should not be treated as participant-level rates without additional detail. The other adverse-event counts equal the corresponding at-risk counts in each cohort listing. That observation describes the posted counts; it does not establish severity, causality, or a treatment effect.
In general, adverse-event counts depend on definitions, follow-up, and how events are collected and attributed. Those details are not reported in the registry record. No statistical comparison of safety between arms is posted, and the available counts should be read as descriptive safety reporting rather than evidence of a comparative difference.
12. What the Result Does, and Does Not, Mean
The posted primary result answers a narrow dose-finding question: the maximum tolerated dose was declared at cohort number 2 for Arm 1, cohort number 2 for Arm 2, cohort number 4 for Arm 3A, and cohort number 2 for Arm 3B. These values indicate the cohort positions recorded for the endpoint. They do not specify the corresponding numeric doses, the toxicity criteria used, or the degree of uncertainty around the decisions.
The values do not show whether the drug combinations controlled glioblastoma or anaplastic glioma. Although the trial summary describes an interest in disease control, no efficacy outcome analysis is posted. The record also contains no comparative treatment-effect estimate, confidence interval, or p-value. It therefore does not support a statistical conclusion about the relative efficacy of the arms.
The adverse-event figures describe serious and other events in the listed arm-cohort groups. Without a posted comparative analysis and additional detail about event definitions and follow-up, they do not establish that one regimen has a different safety profile from another. The listed serious-event terms and deaths should be interpreted as the registry’s descriptive reporting, not as evidence of causation.
The record has an unresolved difference in treatment naming: the primary outcome description refers to carboplatin combinations, while the interventions and Phase I arm descriptions refer to temozolomide. It is not possible to determine from the registry record whether this reflects a wording error or a substantive difference. The record also says the study was terminated but does not state why. These limitations make the posted findings useful for describing the recorded dose-finding endpoint and safety counts, but not for drawing broader conclusions about treatment benefit, comparative risk, or why the trial ended.
13. Why This Trial Matters Statistically
This trial illustrates an important distinction between a dose-finding result and an efficacy result. The primary endpoint is the cohort number at which a maximum tolerated dose was declared. That endpoint can describe a dose-development decision, but it does not quantify tumor response or compare how well regimens control disease. Keeping the endpoint’s meaning separate from the trial’s broader research aim prevents an inappropriate interpretation of cohort numbers as evidence of clinical benefit.
The record also shows why treatment labels and endpoint definitions matter to statistical interpretation. The outcome description names carboplatin, while the listed interventions and Phase I arm descriptions name temozolomide. A reader cannot confidently map the outcome description to the named combinations without clarification. Such inconsistencies are not solved by statistical calculations and can limit the usefulness of otherwise clear numerical results.
Finally, the record distinguishes enrollment from the primary endpoint population: 55 participants were enrolled and 52 were evaluable. It provides reasons for the difference, but does not detail the definition of evaluability or how missing information was handled. These are central reporting features when assessing which participants contribute to a result. The trial’s randomized designation does not replace the need for posted analyses: none are listed, and no treatment-effect estimates are reported. Together, these features show why statistical interpretation depends on matching the reported number to its endpoint, population, and analysis context.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record has several trial-specific limitations for interpretation. The primary outcome description names vorinostat plus isotretinoin, carboplatin plus isotretinoin, and a three-drug combination involving carboplatin. By contrast, the listed interventions and Phase I arm descriptions include temozolomide combinations. The record does not clarify whether this is a naming error or a difference in the regimens. The numeric cohort outcomes should therefore be interpreted alongside this unresolved discrepancy.
The outcome is reported as cohort number, not as the dose amount. Although the outcome description gives dose units, it does not provide dose values corresponding to each reported cohort number. It also does not report the maximum tolerated dose decision criteria, dose-limiting toxicity definitions, or dose-escalation rules. These missing details prevent reconstruction of how the dose decision was reached.
The trial is marked terminated, but the reason for termination is not reported in the registry record. The record reports 55 enrolled and 52 evaluable participants, with two consent withdrawals and one participant who chose not to proceed. It does not define evaluability or describe handling of missing endpoint data beyond those reasons. It also does not post statistical analyses, efficacy comparisons, or secondary results.
The safety data are descriptive counts by arm and cohort. Additional details about event definitions, attribution, and follow-up are not reported in the registry record, and there is no comparative safety analysis. These gaps limit the conclusions that can be drawn from the posted event figures.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Vorinostat, Isotretinoin and Temozolomide in Adults With Recurrent Glioblastoma Multiforme (GBM) — NCT00555399.
- Registry record last updated 2024-08-22; status last verified 2024-07.
- Results first posted 2024-08-22.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This is a randomized, unmasked, parallel Phase I / II study in adults with recurrent glioblastoma multiforme and anaplastic gliomas. The registry lists 55 enrolled participants and a terminated status. The primary endpoint is maximum tolerated dose, reported as cohort number: 2 for Arm 1, 2 for Arm 2, 4 for Arm 3A, and 2 for Arm 3B. The primary endpoint population states that 52 participants were evaluable; two withdrew consent and one chose not to proceed with treatment.
The record includes serious and other adverse-event counts by arm and cohort, but no statistical analyses or treatment-effect estimates are posted. The reason for termination, dose amounts corresponding to the cohort numbers, and the decision rules for declaring the maximum tolerated dose are not reported in the registry record. The endpoint description names carboplatin combinations, while the intervention and Phase I arm descriptions name temozolomide combinations; this difference is not explained.