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Mesothelioma Clinical Trials

Alanosine in Treating Patients With Cancer

This study is currently recruiting patients.

Sponsored by

Memorial Sloan-Kettering Cancer Center
For more information:National Cancer Institute (NCI)
 

RATIONALE: Drugs used in chemotherapy such as alanosine use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of alanosine in treating patients who have soft tissue sarcoma, sarcoma of the bone, mesothelioma, non-small cell lung cancer, or pancreatic cancer.

Condition Treatment or Intervention
Gastrointestinal Cancer
musculoskeletal cancer
Osteosarcoma
thorax and respiratory cancer
 Drug: alanosine
 Procedure: chemotherapy

This is a Phase II test

  • In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.  

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Alanosine in Patients With Methylthioadenosine Phosphorylase (MTAP)-Deficient Cancer

Further Study Details: 

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed malignancy of any of the following types:
  • Soft-tissue sarcoma
  • High grade
  • Chemotherapy na´ve 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 na´ve disease NOTE: *Prior treatment with cisplatin and doxorubicin required
  • Mesothelioma
  • Unresectable
  • Chemotherapy na´ve 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 na´ve disease
  • Pancreatic cancer
  • Stage IV adenocarcinoma after no more than 1 prior cytotoxic treatment regimen
  • No newly diagnosed or chemotherapy na´ve 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  


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