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Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer

Primary Purpose

Brain and Central Nervous System Tumors, Head and Neck Cancer, Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
carmustine
cisplatin
cyclophosphamide
etoposide
thiotepa
adjuvant therapy
autologous bone marrow transplantation
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
Sponsored by
Herbert Irving Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult medulloblastoma, adult oligodendroglioma, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, adult anaplastic astrocytoma, adult central nervous system germ cell tumor, primary central nervous system non-Hodgkin lymphoma, adult anaplastic oligodendroglioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed malignant tumors Anaplastic astrocytoma Oligodendroglioma Germ cell tumor Medulloblastoma Primary neuroectodermal tumor Esthesioneuroblastoma CNS lymphoma (primary or systemic disease) Multifocal intracranial disease allowed No extraneural metastases (except controlled systemic lymphoma) Pretreatment considerations based on tumor type Anaplastic astrocytoma: Recurrent disease Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2) Chemotherapy not required at recurrence Oligodendroglioma: Disease response (at least minor) to conventional chemotherapy OR Recurrent disease Esthesioneuroblastoma: Attempted complete surgical resection Disease progression after radiotherapy Response to chemotherapy regimen comprising cyclophosphamide, etoposide, and cisplatin CNS lymphoma: Disease refractory to methotrexate OR Failure after initial treatment with methotrexate OR Considered at high risk for disease relapse despite initial response Radiographic or pathological confirmation of recurrent disease required Not eligible for other high priority national or institutional clinical studies PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG or Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 times normal Cardiovascular: LVEF at least 45% Pulmonary: DLCO at least 60% predicted OR Approval of pulmonologist Other: Not pregnant or nursing HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy No concurrent steroids as antiemetics Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent barbiturates or acetaminophen Participation in other concurrent supportive care or gene therapy trials allowed

Sites / Locations

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Outcomes

Primary Outcome Measures

Response rate
Disease-free suvival
Overall survival
Toxicity
Quality of life

Secondary Outcome Measures

Full Information

First Posted
January 6, 2001
Last Updated
February 1, 2013
Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00007982
Brief Title
Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer
Official Title
CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with central nervous system cancer.
Detailed Description
OBJECTIVES: Determine the response rate in patients with central nervous system malignancies treated with intensive chemotherapy supported by autologous peripheral blood stem cell transplantation following surgical resection and/or radiotherapy. Determine the disease-free survival and overall survival of this patient population treated with these regimens. Determine the toxicity of this high-dose chemotherapy regimen in these patients. Assess the quality of life of these patients following these treatment regimens. OUTLINE: Patients with anaplastic astrocytoma, esthesioneuroblastoma, germ cell tumor, or primary neuroectodermal tumor undergo initial surgical resection followed by conventional or stereotactic radiotherapy. Patients with germ cell or primary neuroectodermal tumors also receive 4 courses of standard chemotherapy comprising cyclophosphamide, etoposide, and cisplatin prior to high-dose chemotherapy. All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose chemotherapy consolidation. Patients receive thiotepa IV 3 times daily on days -7 to -3, carmustine IV over 1 hour on days -6 to -3, and etoposide IV over 5 hours on days -6 to -3. Patients then undergo transplantation on day 0. Filgrastim (G-CSF) is administered concurrently with stem cell harvesting and transplantation. Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose chemotherapy. Patients are followed every 2-3 months for 1 year and then annually for 5 years. Quality of life is assessed at follow-up. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Head and Neck Cancer, Lymphoma
Keywords
recurrent adult brain tumor, adult medulloblastoma, adult oligodendroglioma, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, adult anaplastic astrocytoma, adult central nervous system germ cell tumor, primary central nervous system non-Hodgkin lymphoma, adult anaplastic oligodendroglioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Drug
Intervention Name(s)
thiotepa
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
bone marrow ablation with stem cell support
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Primary Outcome Measure Information:
Title
Response rate
Title
Disease-free suvival
Title
Overall survival
Title
Toxicity
Title
Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant tumors Anaplastic astrocytoma Oligodendroglioma Germ cell tumor Medulloblastoma Primary neuroectodermal tumor Esthesioneuroblastoma CNS lymphoma (primary or systemic disease) Multifocal intracranial disease allowed No extraneural metastases (except controlled systemic lymphoma) Pretreatment considerations based on tumor type Anaplastic astrocytoma: Recurrent disease Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2) Chemotherapy not required at recurrence Oligodendroglioma: Disease response (at least minor) to conventional chemotherapy OR Recurrent disease Esthesioneuroblastoma: Attempted complete surgical resection Disease progression after radiotherapy Response to chemotherapy regimen comprising cyclophosphamide, etoposide, and cisplatin CNS lymphoma: Disease refractory to methotrexate OR Failure after initial treatment with methotrexate OR Considered at high risk for disease relapse despite initial response Radiographic or pathological confirmation of recurrent disease required Not eligible for other high priority national or institutional clinical studies PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG or Zubrod 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 times normal Cardiovascular: LVEF at least 45% Pulmonary: DLCO at least 60% predicted OR Approval of pulmonologist Other: Not pregnant or nursing HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No other concurrent chemotherapy Endocrine therapy: No concurrent anticancer hormonal therapy No concurrent steroids as antiemetics Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics Other: No concurrent barbiturates or acetaminophen Participation in other concurrent supportive care or gene therapy trials allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles S. Hesdorffer, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer

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