S9926 Temozolomide in Patients With Unresectable/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.

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