Clinical Trial: Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Central Nervous System Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy combined with peripheral stem cell transplantation in treating patients who have central nervous system cancer.

Condition Treatment or Intervention Phase
adult brain tumor
paranasal sinus and nasal cavity cancer
primary central nervous system lymphoma
 Drug: carmustine
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: etoposide
 Drug: filgrastim
 Drug: thiotepa
 Procedure: adjuvant therapy
 Procedure: autologous bone marrow transplantation
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: bone marrow transplantation
 Procedure: chemotherapy
 Procedure: high-dose chemotherapy
 Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy;   Lymphoma;   Nasal Cancer;   Neurologic Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Intensive Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation in Patients With Central Nervous System Malignancies

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

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:


Location and Contact Information


New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
Charles S. Hesdorffer, MD  212-305-4907 

Study chairs or principal investigators

Charles S. Hesdorffer, MD,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068360; CPMC-IRB-8445; CPMC-CAMP-004A; NCI-G00-1881; NCT00007982
Record last reviewed:  September 2003
Last Updated:  December 6, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00007982
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005