Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer - Full Text View

Sponsor:	Herbert Irving Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00007982

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 II

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:

MedlinePlus related topics: Bone Marrow Transplantation Cancer Head and Neck Cancer Lymphoma

Drug Information available for: Cyclophosphamide Thiotepa Cisplatin Etoposide Etoposide phosphate Filgrastim Lenograstim Granulocyte colony-stimulating factor Carmustine

U.S. FDA Resources

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
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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles S. Hesdorffer, MD

Herbert Irving Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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:	March 13, 2010
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:

Head and Neck Neoplasms
Lymphoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nervous System Diseases
Carmustine
Cyclophosphamide
Thiotepa

Cisplatin
Etoposide
Lenograstim
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on February 12, 2012