Alanosine in Treating Patients With Cancer

NCT00062283 | Completed Phase 2

• 3 other identifiers: SALMEDIX-SDX-102-01MSKCC-03029CDR0000304677
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Lung Cancer; Malignant Mesothelioma; Pancreatic Cancer; Sarcoma

Keywords

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

Interventions

L-alanosine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724, United States

Location

Wilshire Oncology Medical Group, Incorporated - La Verne

La Verne, California, 91750, United States

Location

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Lynn Regional Cancer Center West

Boca Raton, Florida, 33428, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Midwest Cancer Research Group, Incorporated

Skokie, Illinois, 60077, United States

Location

St. Vincent's Comprehensive Cancer Center - Manhattan

New York, New York, 10011, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-6838, United States

Location

MD Anderson Cancer Center at University of Texas

Houston, Texas, 77030, United States

Location

U.S. Oncology, Incorporated

Houston, Texas, 77060, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Mesothelioma, Malignant; Pancreatic Neoplasms; Sarcoma; Osteosarcoma; Chondrosarcoma; Carcinoma, Non-Small-Cell Lung

Interventions

alanosine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Pleural Neoplasms; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Paul A. Meyers, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: March 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2009
• Last Updated: June 26, 2013

Record last verified: 2009-12

Locations

US (12)