Combination Chemotherapy and Bone Marrow Transplantation or Peripheral Stem Cell Transplantation in Treating Patients With Oligodendroglioma

NCT ID: NCT00003101

Last Updated: 2013-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-08-31
• Study Completion Date: 2002-01-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with autologous bone marrow transplantation or peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bone marrow transplantation or peripheral stem cell transplantation in treating patients who have oligodendroglioma.

Detailed Description

OBJECTIVES:

• Determine the duration of response in patients with newly diagnosed pure and mixed anaplastic oligodendrogliomas treated with intensive chemotherapy supported by autologous transplantation.
• Determine the neurological and systemic toxic effects of this regimen in these patients.
• Determine the relationship of 1p loss of heterozygosity on radiographic response, progression-free survival, and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

• Mobilization and stem cell harvest: Patients receive filgrastim (G-CSF) subcutaneously daily for up to 7 days followed by peripheral blood stem cell (PBSC) or bone marrow (BM) harvest.
• Induction therapy: All patients then receive induction therapy (PCV) comprising of oral lomustine on day 1, vincristine IV on days 8 and 29, and oral procarbazine on days 8-21. Treatment repeats every 42 days in the absence of progressive disease or unacceptable toxicity. Patients with prior complete resections receive 3 courses of PCV then proceed to high-dose chemotherapy and transplantation as described below, provided tumor has not recurred. Patients with prior partial resections or biopsies receive 2 courses of PCV and are assessed for response; those who achieve complete response (CR) or major partial response (PR) receive 1 more course of PCV. Patients who achieve partial response or have stable disease receive 2 more courses of PCV and are reassessed.
• High-dose chemotherapy and transplantation: Patients who achieve CR or PR receive thiotepa IV on days -8 to -6 and busulfan IV over 2 hours on day -5 to -3. Patients undergo autologous BM or PBSC transplantation on day 0.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 3-5 years.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

busulfan

Intervention Type: DRUG

lomustine

Intervention Type: DRUG

procarbazine hydrochloride

Intervention Type: DRUG

thiotepa

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

autologous bone marrow transplantation

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically proven anaplastic oligodendroglioma OR
• Histologically proven anaplastic mixed glioma (oligoastrocytoma) provided there is an unequivocal and substantial (at least 25%) oligodendroglial element
• No systemic or leptomeningeal metastases (excluding contiguous leptomeninges)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
• SGOT no greater than 2 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• LVEF at least 50%

Pulmonary

• DLCO at least 50% of predicted

Other

• No other serious illness that would preclude study therapy
• No other concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior systemic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior cranial radiotherapy

Surgery

• Prior complete or partial resection, open biopsy, or stereotactic biopsy allowed

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Lisa M. DeAngelis, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, United States

Stanford University Medical Center

Stanford, California, United States

Evanston Northwestern Health Care

Evanston, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Tom Baker Cancer Center - Calgary

Calgary, Alberta, Canada

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

Countries

United States; Canada

Other Identifiers

CDR0000065833

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G97-1335

Identifier Type: -

Identifier Source: secondary_id

97-077

Identifier Type: -

Identifier Source: org_study_id