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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003101 |
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.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Biological: filgrastim Drug: busulfan Drug: lomustine Drug: procarbazine hydrochloride Drug: thiotepa Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma |
Estimated Enrollment: | 60 |
Study Start Date: | August 1997 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
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.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 3-5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Alabama | |
University of Alabama Comprehensive Cancer Center | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Stanford University Medical Center | |
Stanford, California, United States, 94305-5408 | |
United States, Illinois | |
Evanston Northwestern Health Care | |
Evanston, Illinois, United States, 60201 | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
Canada, Alberta | |
Tom Baker Cancer Center - Calgary | |
Calgary, Alberta, Canada, T2N 4N2 | |
Canada, Ontario | |
Cancer Care Ontario-London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 |
Study Chair: | Lisa M. DeAngelis, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000065833, MSKCC-97077, NCI-G97-1335 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003101 History of Changes |
Health Authority: | United States: Federal Government |
adult oligodendroglioma adult anaplastic oligodendroglioma |
Lomustine Vincristine Antimitotic Agents Central Nervous System Neoplasms Thiotepa Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Busulfan |
Tubulin Modulators Neuroepithelioma Oligodendroglioma Glioma Procarbazine Antineoplastic Agents, Phytogenic Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Nervous System Diseases Neoplasms, Nerve Tissue Vincristine Antimitotic Agents Central Nervous System Neoplasms Pharmacologic Actions Neuroectodermal Tumors Neoplasms |
Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Tubulin Modulators Oligodendroglioma Procarbazine Glioma Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Nervous System Neoplasms Neoplasms, Glandular and Epithelial |