Tamoxifen, Carboplatin, and Topotecan in Treating Patients With CNS Metastases or Recurrent Brain or Spinal Cord Tumors

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Tamoxifen may help carboplatin work better by making tumor cells more sensitive to the drug.

PURPOSE: This phase II trial is studying the side effects of giving carboplatin and topotecan together with tamoxifen and to see how well it works in treating patients with central nervous system metastases or recurrent brain or spinal cord tumors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Tamoxifen; Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Epithelial neoplasms metastatic to the central nervous system

• Recurrent or refractory to prior chemotherapeutic or radiotherapeutic regimens or for which no standard chemotherapy or whole brain radiotherapy regimens exist

• Stage IV disease

• Recurrent glial tumors (brain or spinal cord)

• Received prior whole brain radiotherapy or stereotactic radiotherapy OR refused radiotherapy

• Patients with CNS metastases previously treated with radiotherapy are eligible, provided persistent or progressive CNS metastases are documented by MRI eight weeks after the end of radiotherapy

• Patients with glial tumors must show progressive disease by MRI after prior radiotherapy

• Measurable disease in the brain/leptomeninges of the brain or spinal cord with baseline documentation within 4 weeks of study entry

• Must have ≥ 1 lesion that is ≥ 1 cm on MRI scan

• Ineligible for or has refused participation in higher priority institutional protocols

PATIENT CHARACTERISTICS:

• Karnofsky performance status 50-100%

• Life expectancy ≥ 2 months

• Creatinine ≤ 1.5 mg/dL

• WBC 4,000/mm³ OR ANC ≥ 2,000/mm³

• Platelet count ≥ 150,000/mm³

• Bilirubin ≤ 1.5 mg/dL

• ALT and AST < 2 times upper limit of normal

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• No nonmalignant concurrent illness (e.g., cardiovascular or pulmonary) that is either poorly controlled with currently available treatment or of such severity to preclude study entry

• No severe infection

• Patients who are ineligible for lumbar puncture are allowed

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy, immunotherapy, or chemotherapy OR recovered from expected side effects of prior therapy

• No patients who are recovering from major surgery

• No concurrent radiotherapy

• Concurrent steroid or anticonvulsant therapy allowed