Status:
COMPLETED
Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Schering-Plough
Columbia University
Conditions:
Glioblastoma
Gliomas
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Detailed Description
This is a randomized phase II study that will test two different adjuvant temozolomide regimens in patients with newly diagnosed glioblastoma multiforme. The goal of this study is to identify a regime...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 9 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2017
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00200161
Start Date
August 9 2005
End Date
May 4 2017
Last Update
March 7 2018
Active Locations (3)
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1
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan-Kettering Cancer Center at Commack
Commack, New York, United States, 11725
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021