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

Lymphoma Clinical Trial

Official title:

CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007982
• Other study ID #: CDR0000068360
• Secondary ID: CPMC-IRB-8445CPM
• Status: Completed
• Phase: Phase 2
• First received: January 6, 2001
• Last updated: February 1, 2013
• Start date: April 1999
• Est. completion date: May 2008

Study information

• Verified date: July 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lymphoma
• Nervous System Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• carmustine

• cisplatin

• cyclophosphamide

• etoposide

• thiotepa

Procedure:
• adjuvant therapy

• autologous bone marrow transplantation

• bone marrow ablation with stem cell support

• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Herbert Irving Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate			No
Primary	Disease-free suvival			No
Primary	Overall survival			No
Primary	Toxicity			Yes
Primary	Quality of life			No