Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | December 2006 |
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
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in
chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Tamoxifen may make tumor cells more sensitive to radiation therapy and chemotherapy. Giving
radiation therapy together with temozolomide, tamoxifen, and carboplatin may kill more tumor
cells.
PURPOSE: This phase II trial is studying the side effects and how well giving radiation
therapy together with temozolomide, tamoxifen, and carboplatin works in treating patients
with malignant gliomas.
chemotherapy, such as temozolomide and carboplatin, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Tamoxifen may make tumor cells more sensitive to radiation therapy and chemotherapy. Giving
radiation therapy together with temozolomide, tamoxifen, and carboplatin may kill more tumor
cells.
PURPOSE: This phase II trial is studying the side effects and how well giving radiation
therapy together with temozolomide, tamoxifen, and carboplatin works in treating patients
with malignant gliomas.
OBJECTIVES:
- 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.
- 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.
DISEASE CHARACTERISTICS:
- Histologically confirmed glioblastoma multiforme and/or anaplastic astrocytoma
- Supratentorial tumor
- No well-differentiated astrocytoma or glioma with oligodendroglial component
- No multifocal glioma
- Has undergone surgery within the past 6 weeks
- No recurrent glioblastoma multiforme
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Neurological functional status 0-2
- Life expectancy > 12 weeks
- ANC ≥ 1,200/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
- Blood urea nitrogen ≤ 1.5 times ULN
- Total and direct bilirubin ≤ 3 times ULN
- AST and ALT ≤ 3 times ULN
- Alkaline phosphatase ≤ 3 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
completion
- No other malignancies within the past 3 years, except for carcinoma in situ of the
cervix or nonmelanoma skin cancer
- No acquired immune deficiency syndrome (AIDS)
- No major medical illness or psychiatric impairment that would preclude study
compliance
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the head and neck
- No other concurrent therapy for the tumor
We found this trial at
1
site
Encinitas, California 92024
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