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Alanosine in Treating Patients With Cancer

Primary Purpose

Lung Cancer, Malignant Mesothelioma, Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
L-alanosine
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • Wilshire Oncology Medical Group, Incorporated - La Verne
  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
  • Lynn Regional Cancer Center West
  • University of Chicago Cancer Research Center
  • Midwest Cancer Research Group, Incorporated
  • St. Vincent's Comprehensive Cancer Center - Manhattan
  • Memorial Sloan-Kettering Cancer Center
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • MD Anderson Cancer Center at University of Texas
  • U.S. Oncology, Incorporated

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 5, 2003
Last Updated
June 25, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00062283
Brief Title
Alanosine in Treating Patients With Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
L-alanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A. Meyers, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Wilshire Oncology Medical Group, Incorporated - La Verne
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Lynn Regional Cancer Center West
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Midwest Cancer Research Group, Incorporated
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center - Manhattan
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
MD Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
U.S. Oncology, Incorporated
City
Houston
State/Province
Texas
ZIP/Postal Code
77060
Country
United States

12. IPD Sharing Statement

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Alanosine in Treating Patients With Cancer

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