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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: | NCT00119301 |
RATIONALE: Drugs used in chemotherapy, such as methotrexate, trimetrexate glucuronate, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of trimetrexate glucuronate when given together with methotrexate and leucovorin in treating patients with refractory or recurrent osteosarcoma.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: leucovorin calcium Drug: methotrexate Drug: trimetrexate glucuronate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of High Dose Methotrexate With Simultaneous Trimetrexate and Leucovorin in Patients With Recurrent Osteosarcoma |
Estimated Enrollment: | 18 |
Study Start Date: | April 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of trimetrexate glucuronate.
Patients receive high-dose methotrexate IV over 4 hours on days 1 and 8 and oral trimetrexate glucuronate twice daily on days 2-6 and 9-13. Patients also receive leucovorin calcium IV continuously over 24 hours or orally 2 or 4 times daily on days 9-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of trimetrexate glucuronate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 1 Year to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant osteosarcoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Paul A. Meyers, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000434483, MSKCC-IRB-05028 |
Study First Received: | July 12, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00119301 History of Changes |
Health Authority: | United States: Federal Government |
recurrent osteosarcoma |
Antimetabolites Immunologic Factors Clotrimazole Miconazole Leucovorin Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Vitamins Antifungal Agents Methotrexate Osteogenic Sarcoma Micronutrients Trimetrexate |
Vitamin B Complex Tioconazole Osteosarcoma Trace Elements Folic Acid Antagonists Immunosuppressive Agents Recurrence Folic Acid Calcium, Dietary Malignant Mesenchymal Tumor Sarcoma Antirheumatic Agents |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leucovorin Reproductive Control Agents Neoplasms, Connective and Soft Tissue Antifungal Agents Vitamins Therapeutic Uses Abortifacient Agents Methotrexate |
Micronutrients Dermatologic Agents Nucleic Acid Synthesis Inhibitors Trimetrexate Vitamin B Complex Neoplasms by Histologic Type Growth Substances Osteosarcoma Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms, Bone Tissue |