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Home > "S" Clinical Trials Conditions > STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma  STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
For Condition: stage, adult soft tissue sarcoma,Cancer,cellular diagnosis, adult soft tissue sarcoma,adult solid tumor,solid tumor,Gastrointestinal Cancer,adult soft tissue sarcoma,female reproductive cancer,uterine sarcoma,stage, uterine sarcoma,musculoskeletal cancer,body system/site cancer,Muscle Cancer,stage/cell type, small intestine cancer,small intestine cancer,cellular diagnosis, uterine sarcoma
Status: No longer recruiting
Sponsor(s): EORTC Soft Tissue and Bone Sarcoma Cooperative Group ,
Synopsis: RATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective treatment for soft tissue sarcoma. PURPOSE: Phase I/II trial to study the effectiveness of STI571 in treating patients who have recurrent or refractory soft tissue sarcoma.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and associated toxicity of STI571 in patients with refractory or recurrent soft tissue sarcoma. II. Determine the pharmacokinetic profile of this treatment regimen in these patients. III. Determine the objective response and duration of response in these patients with this treatment regimen. PROTOCOL OUTLINE: This is a dose escalation and dose efficacy, multicenter study. In the dose efficacy portion, patients are stratified according to disease type (gastrointestinal stromal tumor vs all other soft tissue sarcomas). Phase I: Patients receive oral STI571 daily for a maximum of 24 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-8 patients receive escalating doses of STI571 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6-8 patients experience dose limiting toxicities. The recommended phase II dose is defined as the dose preceding the MTD. Phase II: Patients receive the recommended phase II dose of STI571 as in phase I. Patients are followed every 8 weeks until disease progression, and then every 16 weeks thereafter. PROJECTED ACCRUAL: Approximately 47-72 patients (7-32 in phase I and 40 in phase II) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 15 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed soft tissue sarcoma; Malignant fibrous histiocytoma; Liposarcoma; Rhabdomyosarcoma; Synovial sarcoma; Malignant paraganglioma; Fibrosarcoma; Leiomyosarcoma; Angiosarcoma; Hemangiopericytoma; Neurogenic sarcoma; Unclassified sarcoma; Miscellaneous sarcoma (including mixed mesodermal tumors of the uterus); Gastrointestinal stromal tumor (GIST) (must be c-kit positive) - No malignant mesothelioma, chondrosarcoma, neuroblastoma, osteosarcoma, Ewing's sarcoma, or embryonal rhabdomyosarcoma - Phase I study and nonGIST phase II study patients: Must have received one prior first line combination chemotherapy regimen or two first line single agent regimens; Adjuvant chemotherapy not considered first line, unless disease progression within 6 months of treatment - Phase II GIST patients: No more than one prior first line combination chemotherapy regimen or two first line single agent regimens; Adjuvant chemotherapy not considered first line, unless disease progression within 6 months of treatment - Measurable disease with evidence of progression in past 6 weeks; Osseous lesions and pleural effusions not considered measurable - No symptomatic or known CNS metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy; No other concurrent local or systemic chemotherapy - Endocrine therapy: No concurrent systemic corticosteroid therapy - Radiotherapy: No prior radiotherapy to sole index lesion; Concurrent radiotherapy to any lesion allowed if not the sole target lesion - Surgery: Not specified - Other: No prior embolization to sole index lesion; No other concurrent investigational drug; No concurrent warfarin --Patient Characteristics-- - Age: 15 and over - Performance status: WHO 0-1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.8 mg/dL; Albumin at least 25 g/L - Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance greater than 65 mL/min - Cardiovascular: No history of cardiovascular disease - Other: No prior or concurrent second primary malignant tumors except adequately treated carcinoma in situ of the cervix or basal cell carcinoma; No other severe illness (including psychosis); Not pregnant; Fertile patients must use effective contraception during and for 6 months following study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JacobVerweij, Study Chair, EORTC Soft Tissue and Bone Sarcoma Cooperative Group
Academisch Ziekenhuis Groningen
Groningen, , 9713 EZ
Netherlands
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Rigshospitalet
Copenhagen, , 2100
Denmark
Royal Marsden NHS Trust
London, England, SW3 6JJ
United Kingdom
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Aarhus Kommunehospital
Aarhus, , DK-8000
Denmark
Herlev Hospital - University Hospital of Copenhagen
Herlev, , DK-2730
Denmark
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Institut Gustave Roussy
Villejuif, , F-94805
France
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
United Kingdom
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Centre Leon Berard
Lyon, , 69373
France
Antoni van Leeuwenhoekhuis
Amsterdam, , 1066 CX
Netherlands
Additional Information:
Study ID Numbers: CDR0000068226; NOVARTIS-CSTI5710203,EORTC-62001-16003
Study Start Date: August 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006357
Other Gastrointestinal Cancer Studies:
1. STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
2. Temozolomide in Treating Patients With Advanced Soft Tissue Sarcoma
3. Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors
4. Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
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STI571 in Treating Patients With Recurrent or Refractory Soft Tissue Sarcoma
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