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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-02191 | |||
| CDR0000570253 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
OUTLINE: Patients are stratified by disease type (epithelial CNS metastases vs recurrent glial tumors).
Patients receive topotecan IV on days 1-3 (72 hours), carboplatin IV over 30 minutes on day 4, and oral tamoxifen twice daily on days 1-7. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) may be treated for 2 additional courses after documentation of CR.
Patients undergo blood sample collection at baseline and then periodically after the first dose of topotecan to obtain plasma pharmacokinetic (PK) measurements of topotecan and tamoxifen. Some patients may also undergo cerebrospinal fluid (CSF) collection to assess peak CSF levels of topotecan and tamoxifen during course 1.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | CBDCA AUC=3 | ||
| tamoxifen citrate | Drug | Tamoxifen 100mg bid | ||
| topotecan hydrochloride | Drug | Topotecan 0.75 g/m2/d | ||
| pharmacological study | Other | Start of tx, hours 24,28 and 72 during Topotecan infusion, and hours 1,2,4 and 6 after end of Topotecan infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Response rate in patients with recurrent glial tumors as assessed by RECIST criteria | All patients who complete at least one cycle of treatment | |
| Response rate in patients with epithelial CNS metastases as assessed by RECIST criteria | All patients who complete at least one cycle of treatment | |
| Reason for going off-study | Reported for all eligible patients | |
| Progression | Reported for all eligible patients | |
| Survival | Reported for all eligible patients |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Epithelial neoplasms metastatic to the central nervous system
Recurrent glial tumors (brain or spinal cord)
Received prior whole brain radiotherapy or stereotactic radiotherapy OR refused radiotherapy
Measurable disease in the brain/leptomeninges of the brain or spinal cord with baseline documentation within 4 weeks of study entry
Ineligible for or has refused participation in higher priority institutional protocols
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J. Morgan, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| D001254 | Astrocytoma |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D004806 | Ependymoma |
| D018315 | Glioma, Subependymal |
| D009837 | Oligodendroglioma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D013629 | Tamoxifen |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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