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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center Albany Medical College Columbia University Norris Comprehensive Cancer Center Northwestern Memorial Hospital University of Pittsburgh Evanston NorthShore University HealthSystem University of Calgary University of Southern California University of Wisconsin, Madison University of Toronto University of Rochester |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00588523 |
The purpose of this study is to see how effective treatment of high doses of chemotherapy is for your tumor. We will also be looking at the side effects and risks of this treatment. You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy tumor cells, but it can also destroy normal bone marrow cells.
These cells produce white blood cells (which fight infection), red blood cells (which carry oxygen) and platelets (which allow your blood to clot). With too few of these cells there is a serious risk of infection and bleeding. Therefore, before treatment begins, we will collect some of your own blood cells, called peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs are thawed and given back to you. These healthy PBPCs will replace the blood cells that the high dose chemotherapy destroys and allow your bone marrow to recover and produce blood cells. In a prior study we treated 69 patients in a similar way. More than half were able to avoid or delay brain radiation. This new study will use a different high dose chemotherapy regimen.
Condition | Intervention | Phase |
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CNS Cancer CNS BRAIN |
Drug: temozolomide followed by high dose busulfan and thiotepa |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma |
Estimated Enrollment: | 60 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
temozolomide followed by high dose busulfan and thiotepa
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Drug: temozolomide followed by high dose busulfan and thiotepa
Temozolomide 200mg/m2 PO Days 1-5 recycled every 28 days Day minus -8 thiotepa 250 mg/m2 intravenously Day minus -7 thiotepa 250 mg/m2 intravenously Day minus -6 thiotepa 250 mg/m2 intravenously Day minus -5 busulfan 3.2 mg/kg intravenously over two hours Day minus -4 busulfan 3.2 mg/kg intravenously over two hours Day minus -3 busulfan 3.2 mg/kg intravenously over two hours Day minus -2 rest Day minus -1 rest Day 0 peripheral blood stem cell or bone marrow reinfusion
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lauren Abrey, MD | 212-639-5122 | abreyl@mskcc.org |
Contact: Lisa De Angelis, MD | 212-639-7997 | deangell@mskcc.org |
United States, New Jersey | |
Memoral Sloan Kettering Cancer Center | Recruiting |
Basking Ridge, New Jersey, United States | |
Contact: Lauren Abrey, MD 212-639-5122 abreyl@mskcc.org | |
Principal Investigator: Lauren Abrey, MD | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Lauren Abrey, MD 212-639-5122 abreyl@mskcc.org | |
Contact: Lisa De Angelis, MD 212-639-7123 deangell@mskcc.org | |
Principal Investigator: Lauren Abrey, MD | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
Commack, New York, United States | |
Contact: Lauren Abrey, MD 212-639-5122 abreyl@mskcc.org | |
Principal Investigator: Lauren Abrey, MD |
Principal Investigator: | Lauren Abrey, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Lauren Abrey, MD ) |
Study ID Numbers: | 02-089 |
Study First Received: | December 22, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00588523 History of Changes |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
Brain CNS TEMOZOLOMIDE Busulfan Thiotepa |
Immunologic Factors Central Nervous System Neoplasms Temozolomide Immunosuppressive Agents Thiotepa Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Busulfan Neuroepithelioma Oligodendroglioma Glioma Antineoplastic Agents, Alkylating Alkylating Agents Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Temozolomide Immunosuppressive Agents Pharmacologic Actions Thiotepa Neuroectodermal Tumors |
Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Busulfan Myeloablative Agonists Oligodendroglioma Antineoplastic Agents, Alkylating Glioma Neoplasms, Neuroepithelial Alkylating Agents Neoplasms, Glandular and Epithelial |