S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed unresectable or metastatic gastrointestinal stromal tumor (GIST)
• * Primary (gastrointestinal or intra-abdominal origin) tumor
• At least 1 measurable lesion by x-ray, CT, MRI, ultrasound, or physical examination
• * If lesions within prior radiation port are used as target lesions for response assessment, those lesions must have demonstrated clear progression after completion of radiotherapy
• No uterine or retroperitoneal sarcomas or non-intra-abdominal leiomyosarcomas
• PATIENT CHARACTERISTICS:
• Age:
• Not specified
• Performance status:
• Zubrod 0-2
• Life expectancy:
• Not specified
• Hematopoietic:
• WBC (white blood count) at least 3,000/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic:
• Bilirubin no greater than 2 times upper limit of normal (ULN)
• Renal:
• Creatinine no greater than 1.5 times ULN
• Other:
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No medical or psychological conditions that would preclude study participation
• No major infection requiring systemic antibiotics
• No uncontrolled bacterial, viral, or fungal infection
• No other prior malignancy within the past 5 years except:
• * Adequately treated basal cell or squamous cell skin cancer
• * Adequately treated stage I or II cancer in complete remission
• * Carcinoma in situ of the cervix
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• At least 30 days since prior biologic therapy
• Prior imatinib mesylate as adjuvant therapy or for metastatic disease allowed
• Chemotherapy:
• No prior chemotherapy for GIST
• At least 30 days since other prior chemotherapy
• Endocrine therapy:
• Not specified
• Radiotherapy:
• See Disease Characteristics
• No prior radiotherapy for GIST
• No concurrent radiotherapy for GIST
• Concurrent palliative radiotherapy for painful metastases (encompassing a total portal of no greater than 5 x 5 cm) allowed
• Surgery:
• See Disease Characteristics
• At least 4 weeks since prior major surgery and recovered
• Other:
• At least 30 days since prior investigational drugs