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Alanosine in Treating Patients With Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00062283
First received: June 5, 2003
Last updated: June 25, 2013
Last verified: December 2009
  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 2

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2003
Study Completion Date: December 2009
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062283

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
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Paul A. Meyers, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00062283     History of Changes
Other Study ID Numbers: SALMEDIX-SDX-102-01, MSKCC-03029, CDR0000304677
Study First Received: June 5, 2003
Last Updated: June 25, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lung Neoplasms
Mesothelioma
Neoplasms, Mesothelial
Pancreatic Neoplasms
Sarcoma
Adenoma
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Alanosine
Antibiotics, Antineoplastic
Antineoplastic Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014