Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
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:
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)
At least 1 measurable lesion by x-ray, CT, MRI, ultrasound, or physical examination
No uterine or retroperitoneal sarcomas or non-intra-abdominal leiomyosarcomas
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
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:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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