Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

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.

Detailed description: 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: 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

Relevance to patient case: not relevant