Phase 2
N=85
Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma
Glioblastoma · Gliomas
Bottom Line
View on ClinicalTrials.gov: NCT00200161 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: 12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid. — 69; 80 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Temozolomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid. |
69; 80 | — |
| SECONDARY Progression Free Survival at 6 Months |
46; 56 | — |
| SECONDARY Prognostic Impact of Methylated MGMT Status. |
— | — |
| SECONDARY To Collect Preliminary Data on the Efficacy of This Regimen and Impact of MGMT Status in Other Malignant Glioma Subtypes. |
— | — |
Summary
Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone. Patients will receive standard low dose temozolomide during radiation. After radiation, they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide.
Eligibility Criteria
Inclusion Criteria
- Pathologic evidence of a malignant glioma.
- Tissue block or unstained slides must be available for MGMT analysis.
- Age 18-70
- KPS > 50
- Granulocyte count >1.5 X 109/L
- Platelet count >99 X 109/L
- SGOT < 2.5X upper limit of normal (ULN).
- Serum creatinine < 2X ULN.
- Bilirubin < 2X ULN.
- All patients must sign written informed consent.
Exclusion Criteria
- Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
- Any prior experimental therapy for glioma.
- Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
- Serious medical or psychiatric illness that would in the opinion of the investigator would interfere with the prescribed treatment.
- Pregnant or breast feeding women.
- Refusal to use effective contraception.
Data sourced from ClinicalTrials.gov (NCT00200161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.