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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00007982
First received: January 6, 2001
Last updated: February 1, 2013
Last verified: July 2007
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Head and Neck Cancer
Lymphoma
Biological: filgrastim
Drug: carmustine
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: thiotepa
Procedure: adjuvant therapy
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Disease-free suvival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 1999
Study Completion Date: May 2008
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00007982

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
Investigators
Study Chair: Charles S. Hesdorffer, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00007982     History of Changes
Other Study ID Numbers: CDR0000068360, CPMC-IRB-8445, CPMC-CAMP-004A, NCI-G00-1881
Study First Received: January 6, 2001
Last Updated: February 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Head and Neck Neoplasms
Lymphoma
Nervous System Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Cyclophosphamide
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014