s9926 temozolomide in patients with unresectable/metastatic gastrointestinal stromal tumors

Conditions: Gastrointestinal Stromal Tumor

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of temozolomide in treating patients who have unresectable or metastatic gastrointestinal stromal tumors.

objectives: * determine the complete and partial response (confirmed and unconfirmed) in patients with unresectable or metastatic gastrointestinal stromal tumors treated with temozolomide. * determine the qualitative or quantitative toxic effects of this regimen in these patients. outline: this is a multicenter study. patients receive oral temozolomide once daily on days 1-5. treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. patients achieving a confirmed complete response (cr) receive 2 additional courses after a confirmed cr. patients are followed every 3 months for 1 year and then every 6 months for 2 years. projected accrual: a total of 20-40 patients will be accrued for this study within 13-27 months.

Eligibility criteria:
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

Keywords: gastrointestinal stromal tumor