S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

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