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.
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 12 Locations for this study
Birmingham Alabama, 35294, United States
Tucson Arizona, 85724, United States
La Verne California, 91750, United States
Los Angeles California, 90048, United States
Boca Raton Florida, 33428, United States
Chicago Illinois, 60637, United States
Skokie Illinois, 60077, United States
New York New York, 10011, United States
New York New York, 10021, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Houston Texas, 77060, United States
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.