Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma

• Status: Completed
• Trial end date: 2017-05-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Columbia University; Dana-Farber Cancer Institute; Schering-Plough
• Treatments: Dacarbazine; Isotretinoin; Temozolomide; Tretinoin

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.