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

NCT00003101 | Completed Phase 2

• 3 other identifiers: 97-077CDR0000065833NCI-G97-1335
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 7

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult oligodendroglioma; adult anaplastic oligodendroglioma

Interventions

filgrastim BIOLOGICAL

busulfan DRUG

lomustine DRUG

procarbazine hydrochloride DRUG

thiotepa DRUG

vincristine sulfate DRUG

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

Evanston Northwestern Health Care

Evanston, Illinois, 60201, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Oligodendroglioma

Interventions

Filgrastim; Busulfan; Lomustine; Procarbazine; Thiotepa; Vincristine; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Phosphoramides; Organophosphorus Compounds; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Lisa M. DeAngelis, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 21, 2004
• Study Start: August 1, 1997
• Primary Completion: January 1, 2002
• Study Completion: January 1, 2002
• Last Updated: June 25, 2013

Record last verified: 2013-06

Locations

US (5); CA (2)