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Alanosine in Treating Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00062283
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : June 26, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE June 5, 2003
First Posted Date  ICMJE June 6, 2003
Last Update Posted Date June 26, 2013
Study Start Date  ICMJE March 2003
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alanosine in Treating Patients With Cancer
Official Title  ICMJE A Phase II, Open-Label, Non-Randomized, Multicenter, Single Agent Study of Intravenous SDX-102 for the Treatment of Patients With MTAP-Deficient Cancer
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Malignant Mesothelioma
  • Pancreatic Cancer
  • Sarcoma
Intervention  ICMJE Drug: L-alanosine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00062283
Other Study ID Numbers  ICMJE SALMEDIX-SDX-102-01
MSKCC-03029
CDR0000304677 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Paul A. Meyers, MD Memorial Sloan Kettering Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP