S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

Conditions
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Gastrointestinal Stromal Tumor

Intervention / Treatment
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* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temozolomide<br>200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle. | Drug: temozolomide<br>* 200 mg/m^2/day, PO, on Days 1-5 of each 28 day cycle.<br>* Other names: NSC-362856;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess response (confirmed & unconfirmed, complete & partial response) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal stromal tumor