Alanosine in Treating Patients With Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer Malignant Mesothelioma Pancreatic Cancer Sarcoma

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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L-alanosine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No