Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas
|ClinicalTrials.gov Identifier: NCT00492687|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : June 27, 2007
Last Update Posted : January 10, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: carboplatin Drug: tamoxifen citrate Drug: temozolomide Procedure: adjuvant therapy Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2006|
|Estimated Primary Completion Date :||July 2009|
- Progression-free survival
- Overall survival
- Tumor response
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00492687
|United States, California|
|San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas||Recruiting|
|Encinitas, California, United States, 92024|
|Contact: Edward F. McClay, MD 760-452-3340 firstname.lastname@example.org|
|Principal Investigator:||Edward F. McClay, MD||San Diego Pacific Oncology & Hematology Associates|