Alanosine in Treating Patients With Cancer

June 25, 2013 updated by: Memorial Sloan Kettering Cancer Center

A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • California
      • La Verne, California, United States, 91750
        • Wilshire Oncology Medical Group, Incorporated - La Verne
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Lynn Regional Cancer Center West
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Skokie, Illinois, United States, 60077
        • Midwest Cancer Research Group, Incorporated
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center - Manhattan
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center at University of Texas
      • Houston, Texas, United States, 77060
        • U.S. Oncology, Incorporated

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 5, 2003

First Submitted That Met QC Criteria

June 5, 2003

First Posted (Estimate)

June 6, 2003

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALMEDIX-SDX-102-01
  • MSKCC-03029
  • CDR0000304677 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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