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| Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center 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 |
| MedlinePlus related topics: | Cancer Lung Cancer Mesothelioma Pancreatic Cancer Soft Tissue Sarcoma |
| ChemIDplus related topics: | Pancrelipase Ultrase |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 |
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 | |||||
| Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | |||||
| Los Angeles, California, United States, 90048 | |||||
| Wilshire Oncology Medical Group, Incorporated - La Verne | |||||
| La Verne, California, United States, 91750 | |||||
| United States, Florida | |||||
| Lynn Regional Cancer Center West | |||||
| Boca Raton, Florida, United States, 33428 | |||||
| United States, Illinois | |||||
| Midwest Cancer Research Group, Incorporated | |||||
| Skokie, Illinois, United States, 60077 | |||||
| University of Chicago Cancer Research Center | |||||
| Chicago, Illinois, United States, 60637-1470 | |||||
| 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 | |||||
| Memorial Sloan-Kettering Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Paul A. Meyers, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000304677, MSKCC-03029, SALMEDIX-SDX-102-01 |
| First Received: | June 5, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00062283 |
| Health Authority: | United States: Federal Government |
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