Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas

NCT ID: NCT00492687

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

carboplatin

Intervention Type: DRUG

tamoxifen citrate

Intervention Type: DRUG

temozolomide

Intervention Type: DRUG

adjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Diego Pacific Oncology & Hematology Associates

OTHER

Sponsor Role: lead

Principal Investigators

Edward F. McClay, MD

Role: PRINCIPAL_INVESTIGATOR

San Diego Pacific Oncology & Hematology Associates

Locations

San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas

Encinitas, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Edward F. McClay, MD

Role: primary

emcclay@pacificoncology.com

760-452-3340

Other Identifiers

POHA-0601

Identifier Type: -

Identifier Source: secondary_id

CDR0000551555

Identifier Type: -

Identifier Source: org_study_id