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Home > "A" Clinical Trials Conditions > Alanosine in Treating Patients With Cancer  Alanosine in Treating Patients With Cancer
Alanosine in Treating Patients With Cancer
For Condition: musculoskeletal cancer,thorax and respiratory cancer,Gastrointestinal Cancer,Osteosarcoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as alanosine use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of alanosine in treating patients who have soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or pancreatic cancer.
Details: OBJECTIVES: - Determine the response rates in patients with methylthioadenosine phosphorylase (MTAP)-deficient cancer when treated with alanosine. - Determine the time to response and duration of response in patients treated with this drug. - Determine the progression-free survival of patients treated with this drug. - Determine the pharmacodynamic activity of this drug in these patients, based on special imaging to measure tumor adenosine triphosphate depletion. - Determine the pharmacokinetic activity of this drug in these patients. - Determine the safety and tolerability of this drug in these patients. 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed malignancy of any of the following types: - Soft-tissue sarcoma - High grade - Chemotherapy naïve or progressive or metastatic after no more than 2 prior cytotoxic treatment regimens (not including adjuvant therapy) - Sarcoma of the bone (including osteosarcoma* and chondrosarcoma) - High grade - Progressive or recurrent after no more than 2 prior cytotoxic treatment regimens - No newly diagnosed or chemotherapy naïve disease NOTE: *Prior treatment with cisplatin and doxorubicin required - Mesothelioma - Unresectable - Chemotherapy naïve or progressive after no more than 1 prior cytotoxic chemotherapy regimen - Not amenable to curative treatment with surgery - Evidence of gross unresectability includes, but is not limited to, direct extension into the chest wall, mediastinal or hilar lymphadenopathy, pulmonary or cardiac function that is inadequate to tolerate resection, and sarcomatoid or mixed histology - Non-small cell lung cancer - Stage III with malignant pleural or pericardial effusion, stage IV, or progressive after no more than 2 prior cytotoxic chemotherapy regimens - No newly diagnosed or chemotherapy naïve disease - Pancreatic cancer - Stage IV adenocarcinoma after no more than 1 prior cytotoxic treatment regimen - No newly diagnosed or chemotherapy naïve disease - No Ewing's sarcoma of the soft tissue or bone - Documented absence of methylthioadenosine phosphorylase on fixed tumor specimens - Measurable disease - For all tumor types, at least 1 lesion measurable by MRI or CT scan - Chest x-ray allowed only for clearly defined lesions surrounded by aerated lung - Soft tissue component of bone disease considered measurable provided it can be measured by MRI or CT scan - Must be outside of a previously irradiated area - No uncontrolled CNS metastases of primary tumor under study - Patients with brain metastases are eligible only if the brain metastases have been treated with prior radiotherapy and/or surgery, are neurologically stable with no progressing symptoms, and are off steroids and anticonvulsants PATIENT CHARACTERISTICS: Age - 18 and over (13 and over for osteosarcoma only) Performance status - WHO 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases are present) Renal - Creatinine no greater than 1.5 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 4 weeks after study treatment - No premalignant bony lesions (e.g., Paget's disease) - No other concurrent active malignancy except completely excised nonmelanoma skin cancer or carcinoma in situ of the cervix or bladder - No serious infection - No medical or psychiatric condition that would preclude the achievement of the study objectives PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - More than 42 days since prior nitrosoureas or mitomycin Endocrine therapy - See Disease Characteristics Radiotherapy - See Disease Characteristics - At least 28 days since prior brain radiotherapy - More than 28 days since prior radiotherapy to more than 50% of the bone marrow Surgery - See Disease Characteristics - At least 28 days since prior thoracic or other major surgery Other - Recovered from prior therapy - More than 28 days since prior cytotoxic agents - More than 28 days since prior anticancer investigational agents - No other concurrent anti-tumor treatment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeeKrug, Study Chair, Memorial Sloan-Kettering Cancer Center
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Francisco Robert 205-934-5092
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Lee Krug 212-639-8420
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Edward Kim 713-792-6363
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6838
United States
Recruiting Alan Sandler 615-343-9238
Midwest Cancer Research Group, Incorporated *Recruiting*
Skokie, Illinois, 60077
United States
Recruiting Ira Oliff 847-673-1999
Wilshire Oncology Medical Group, Incorporated - La Verne *Recruiting*
La Verne, California, 91750
United States
Recruiting Douglas Blaney 909-596-5333 ext. 228
Lynn Regional Cancer Center West *Recruiting*
Boca Raton, Florida, 33428
United States
Recruiting Israel Wiznitzer 561-883-7600
U.S. Oncology, Incorporated *Recruiting*
Houston, Texas, 77060
United States
Recruiting Marcus Neubauer 832-601-6447
Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson, Arizona, 85724
United States
Recruiting Michael Lobell 520-626-6824
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Ronald Natale 310-423-0721
St. Vincents Comprehensive Cancer Center *Recruiting*
New York City, New York, 10011
United States
Recruiting Gerald Rosen 212-367-1729
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Hedy Kindler 773-702-0360
Additional Information:
Study ID Numbers: CDR0000304677; SALMEDIX-SDX-102-01,MSKCC-03029
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062283
Other Gastrointestinal Cancer Studies:
1. Alanosine in Treating Patients With Cancer
2. STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
3. High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer
4. Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
5. Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
Related Studies:
Other Gastrointestinal Cancer Clinical Trials
Other California Clinical Trials
Other La Verne Clinical Trials
Alanosine in Treating Patients With Cancer
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