Trial record 6 of 124 for:    Brain and Spinal Tumors

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00541138
First received: October 5, 2007
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: carboplatin
Drug: tamoxifen citrate
Drug: topotecan hydrochloride
Other: pharmacological study
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Toxicity profile as assessed by NCI CTC v2.0 [ Time Frame: All patients who complete one course of therapy and are followed a minimum of 3 weeks after completion of first course of therapy ] [ Designated as safety issue: Yes ]
  • Response rate in patients with recurrent glial tumors as assessed by RECIST criteria [ Time Frame: All patients who complete at least one cycle of treatment ] [ Designated as safety issue: No ]
  • Response rate in patients with epithelial CNS metastases as assessed by RECIST criteria [ Time Frame: All patients who complete at least one cycle of treatment ] [ Designated as safety issue: No ]
  • Reason for going off-study [ Time Frame: Reported for all eligible patients ] [ Designated as safety issue: No ]
  • Progression [ Time Frame: Reported for all eligible patients ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: Reported for all eligible patients ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: May 2003
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: carboplatin
    CBDCA AUC=3
    Drug: tamoxifen citrate
    Tamoxifen 100mg bid
    Drug: topotecan hydrochloride
    Topotecan 0.75 g/m2/d
    Other: pharmacological study
    Start of tx, hours 24,28 and 72 during Topotecan infusion, and hours 1,2,4 and 6 after end of Topotecan infusion.
Detailed Description:

OBJECTIVES:

  • To evaluate the systemic and CNS response rates and progression-free and overall survival of patients with epithelial cancer and brain metastases treated with tamoxifen citrate, topotecan hydrochloride, and carboplatin.
  • To evaluate the response rates, progression-free survival, and overall survival of patients with recurrent primary glial tumors treated with this regimen.
  • To further assess the toxicity of these drugs in these patients.
  • To further evaluate the pharmacokinetics of topotecan hydrochloride and tamoxifen citrate using paired specimens of cerebrospinal fluid and plasma from these patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541138

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Robert J. Morgan, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00541138     History of Changes
Other Study ID Numbers: 02191, P30CA033572, CHNMC-02191, CDR0000570253
Study First Received: October 5, 2007
Last Updated: September 20, 2011
Health Authority: United States: Federal Government

Keywords provided by City of Hope Medical Center:
tumors metastatic to brain
recurrent adult brain tumor
adult brain stem glioma
unspecified adult solid tumor, protocol specific
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 anaplastic ependymoma
adult ependymoma
adult myxopapillary ependymoma
adult subependymoma
adult anaplastic oligodendroglioma
adult oligodendroglioma
adult mixed glioma

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Nervous System Neoplasms
Spinal Cord Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Spinal Cord Diseases
Neoplastic Processes
Pathologic Processes
Nervous System Diseases
Central Nervous System Diseases
Tamoxifen
Carboplatin
Topotecan
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014