Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Pilot Study of Tamoxifen, Carboplatin and Topotecan in the Treatment of Recurrent or Refractory Primary Brain or Spinal Cord Tumors or Metastatic Epithelial Cancers With Central Nervous System Metastases
Verified date | September 2011 |
Source | City of Hope Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | October 2007 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
Lead Sponsor | Collaborator |
---|---|
City of Hope Medical Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity profile as assessed by NCI CTC v2.0 | All patients who complete one course of therapy and are followed a minimum of 3 weeks after completion of first course of therapy | Yes | |
Primary | Response rate in patients with recurrent glial tumors as assessed by RECIST criteria | All patients who complete at least one cycle of treatment | No | |
Primary | Response rate in patients with epithelial CNS metastases as assessed by RECIST criteria | All patients who complete at least one cycle of treatment | No | |
Primary | Reason for going off-study | Reported for all eligible patients | No | |
Primary | Progression | Reported for all eligible patients | No | |
Primary | Survival | Reported for all eligible patients | No |
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