Clinical trial · Interventional
S9926 Temozolomide in Patients With Unresectable/Metastatic Gastrointestinal Stromal Tumors
Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)
NCT00005597CI-TRIAL-00008778completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide
- description
- 200 mg/m\^2/day, PO, on Days 1-5 of each 28 day cycle.
- interventionNames
- Drug: temozolomide
Primary outcomes (1)
- measure
- Assess response (confirmed & unconfirmed, complete & partial response)
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- Toxicities
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.