Lung Cancer Clinical Trial

Alanosine in Treating Patients With Cancer

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT00062283

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 12 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT00062283

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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