Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CPMC-IRB-8445 CPMC-CAMP-004A, NCI-G00-1881, NCT00007982

Objectives

1. 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.
2. Determine the disease-free survival and overall survival of this patient population treated with these regimens.
3. Determine the toxicity of this high-dose chemotherapy regimen in these patients.
4. Assess the quality of life of these patients following these treatment regimens.

Entry 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

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

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

Expected Enrollment

A total of 30 patients will be accrued for this study over 3 years.

Outcomes

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

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.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Charles Hesdorffer, MD, Protocol chair		Ph: 212-305-4907 Email: csh1@columbia.edu

Registry Information
Official Title		CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor
Trial Start Date		1999-04-28
Trial Completion Date		2005-02-01
Registered in ClinicalTrials.gov		NCT00007982 1
Date Submitted to PDQ		2000-11-06
Information Last Verified		2007-07-11
NCI Grant/Contract Number		CA13696

Table of Links

1	http://clinicaltrials.gov/ct/show/NCT00007982