A Phase II Pilot Trial of Radiation Therapy With Concurrent and Adjuvant Temozolomide, Tamoxifen and Carboplatin (T2C) in the Treatment of Patients With Primary Central Nervous System Malignant Gliomas
- Determine the progression-free and overall survival of patients with supratentorial
malignant gliomas (WHO grade III or IV) receiving radiotherapy with concurrent and
adjuvant temozolomide, tamoxifen citrate, and carboplatin.
- Determine the acute and delayed treatment-related toxicities in these patients.
- Determine tumor response in patients with postoperative measurable disease.
OUTLINE: This is an open-label, pilot study.
- Induction therapy: Patients receive oral temozolomide twice daily and oral tamoxifen
citrate twice daily on days 1-42 and carboplatin IV over 60 minutes on days 1, 8, 15,
22, 29, and 36. Patients also receive radiotherapy on days 1-5 in weeks 1-6.
- Consolidation therapy: Beginning 4 weeks after the completion of induction therapy,
patients receive temozolomide, tamoxifen citrate, and carboplatin as in induction
therapy. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
Masking: Open Label, Primary Purpose: Treatment
Edward F. McClay, MD
San Diego Pacific Oncology & Hematology Associates
|San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas||Encinitas, California 92024|