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

NCT00541138 | Completed Phase 2

• 4 other identifiers: 02191P30CA033572CHNMC-02191CDR0000570253
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain and Central Nervous System Tumors; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

tumors metastatic to brain; recurrent adult brain tumor; adult anaplastic astrocytoma; adult diffuse astrocytoma; adult giant cell glioblastoma; adult gliosarcoma; adult pilocytic astrocytoma; adult pineal gland astrocytoma; adult subependymal giant cell astrocytoma; adult brain stem glioma; adult anaplastic ependymoma; adult ependymoma; adult myxopapillary ependymoma; adult subependymoma; adult anaplastic oligodendroglioma; adult oligodendroglioma; unspecified adult solid tumor, protocol specific; adult mixed glioma

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Astrocytoma; Glioblastoma; Gliosarcoma; Ependymoma; Glioma, Subependymal; Oligodendroglioma; Glioma

Interventions

Carboplatin; Tamoxifen; Topotecan

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Robert J. Morgan, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: May 1, 2003
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: September 21, 2011

Record last verified: 2011-09

Locations

US (1)