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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00062283 |
Purpose
RATIONALE: Drugs used in chemotherapy such as alanosine use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well alanosine works in treating patients with soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or pancreatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer Malignant Mesothelioma Pancreatic Cancer Sarcoma |
Drug: L-alanosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer |
| Study Start Date: | March 2003 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive alanosine IV continuously on days 1-5. Treatment repeats every 21 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 28 days.
PROJECTED ACCRUAL: A total of 50-145 patients (10-29 per tumor type) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignancy of any of the following types:
Soft-tissue sarcoma
Sarcoma of the bone (including osteosarcoma* and chondrosarcoma)
Mesothelioma
Not amenable to curative treatment with surgery
Non-small cell lung cancer
Pancreatic cancer
Measurable disease
No uncontrolled CNS metastases of primary tumor under study
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Wilshire Oncology Medical Group, Incorporated - La Verne | |
| La Verne, California, United States, 91750 | |
| Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| United States, Florida | |
| Lynn Regional Cancer Center West | |
| Boca Raton, Florida, United States, 33428 | |
| United States, Illinois | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Midwest Cancer Research Group, Incorporated | |
| Skokie, Illinois, United States, 60077 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| St. Vincent's Comprehensive Cancer Center - Manhattan | |
| New York, New York, United States, 10011 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
| United States, Texas | |
| MD Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030 | |
| U.S. Oncology, Incorporated | |
| Houston, Texas, United States, 77060 | |
| Study Chair: | Paul A. Meyers, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00062283 History of Changes |
| Other Study ID Numbers: | CDR0000304677, MSKCC-03029, SALMEDIX-SDX-102-01 |
| Study First Received: | June 5, 2003 |
| Last Updated: | December 11, 2009 |
| Health Authority: | United States: Federal Government |
|
advanced malignant mesothelioma recurrent malignant mesothelioma metastatic osteosarcoma recurrent osteosarcoma recurrent adult soft tissue sarcoma stage IV adult soft tissue sarcoma chondrosarcoma recurrent non-small cell lung cancer |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the pancreas recurrent pancreatic cancer stage III adult soft tissue sarcoma stage II adult soft tissue sarcoma stage IV pancreatic cancer |
|
Lung Neoplasms Mesothelioma Pancreatic Neoplasms Sarcoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Mesothelial |
Digestive System Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Neoplasms, Connective and Soft Tissue Alanosine Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses |