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Home > "P" Clinical Trials Conditions > Phase II Trial of Gleevec (STI571) in Patients with Advanced Soft Tissue or Bone Cancer  Phase II Trial of Gleevec (STI571) in Patients with Advanced Soft Tissue or Bone Cancer
Phase II Trial of Gleevec (STI571) in Patients with Advanced Soft Tissue or Bone Cancer
For Condition: Sarcoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will evaluate the safety and effectiveness of the experimental drug Gleevec in patients with soft tissue or bone cancers that have spread or recurred after standard treatment. Gleevec has stopped tumor cell growth and eventually led to tumor cell death with minimal side effects in other forms of cancer. Laboratory and clinical studies suggest that Gleevec may be able to induce remissions in sarcomas as well. Patients 10 years of age and older with advanced soft tissue or bone cancer may be eligible for this study. These cancers may include Ewing's sarcoma, osteosarcoma, synovial sarcoma, leiomyosarcoma, rhabdomyosarcoma, liposarcoma, malignant fibrous histiocytoma, peripheral nerve sheath, fibrosarcoma, and angiosarcoma. Pregnant and nursing women may not participate. Participants will take Gleevec by mouth twice a day for up to 12 months. They will record the doses of Gleevec and any drug side effects. Routine blood tests will be done every 2 weeks for the first 16 weeks of the study, and at least every 4 weeks after that. Scans will be taken to monitor the status of the tumor before starting Gleevec and after 8 weeks of treatment. If the tumor has remained stable in size or gotten smaller, treatment and evaluations will continue on the same schedule in 8-week cycles for a maximum of 12 months. Patients who develop signs or symptoms that the drug is either not controlling the tumor or that it is no longer safe will be taken off the study.
Details: Soft tissue and bone sarcomas represent a small proportion of the malignancies that are seen in North America. However, these sarcomas tend to affect a population of children, adolescents and young adults making the disease even more tragic. Patients afflicted with recurrent or metastatic sarcomas have a poor survival rate with standard treatments and therapies available today. Gleevec, formerly known as STI 571, is a compound that specifically inhibits BCR-ABL, c-kit, and PDGF Tyrosine kinases. After demonstration of remarkable activity against BCR-ABL positive CML, this drug was recently tested against GIST because these tumors have activating point mutations on c-kit. Remarkable anti-tumor activity with minimal toxicity was once again demonstrated. A variety of sarcomas have been shown to have activated c-kit or PDGF activity. Based on the activity and high therapeutic index of Gleevec, this protocol will assess the efficacy of Gleevec in patients with unresectable, recurrent or metastatic sarcomas who have failed prior treatment regimen(s), and will also assess the toxicities of Gleevec in a variety of sarcoma patients.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA A.Patients must have pathologically verified diagnosis, of an eligible soft tissue or bone sarcoma with histologic, cytologic or clinical evidence of metastatic or locally advanced disease (stage IV or recurrent). Eligible histologic subtypes include: Ewing's Family (including PNET), osteosarcoma, synovial sarcoma, leiomyosarcoma, rhabdomyosarcoma (alveolar, embryonal and pleomorphic), liposarcoma (all variants), malignant fibrous histiocytoma, peripheral nerve sheath (including MPNST, neurofibrosarcoma, schwannoma), fibrosarcoma, angiosarcoma (all variants). B. All patients should have failed standard therapy with no available salvage regimens. C. Patients must have unidimensionally measurable lesions targeted either by x-ray, CT, MRI, PET or physical examination documented within 28 days prior to registration. D. Prior radiation will be allowed. Three weeks should have elapsed since the administration of the last fraction of radiation therapy and patients must have recovered from all associated toxicities. All measureable lesions which are being targeted must be outside previously radiated fields or have documented progression at least 6 weeks after completion of radiation. E. At least 28 days or more should have elapsed since patient has received any prior systemic therapy. F. Patients must have adequate hepatic function as defined by a serum bilirubin up to 3.0 x the institutional upper limit of normal (ULN) within 14 days of registration. G. Patients must have serum creatine less than 1.5x the institutional ULN (adjusted for age) within 14 days of registration. H. ALT and AST less than 2.5x ULN within 14 days of registration. I. Men/women of reproductive potential must agree to use an effective barrier contraceptive method. J. Women who are pregnant or nursing will not be eligible. K. Patients must be physically, mentally and emotionally able to give informed consent. (Parental informed consent must be given for patients under 18). L. Pediatric patients must be at least 10 years old. M. A paraffin block or at least 6 unstained slides of tumor sample either from a previous surgery or recent biopsy must be available. Snap-frozen tumor of a new biopsy and sera storage of plasma is encouraged for each patient and is to be stored at the institution.
Total Enrollment: 120
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 020097; 02-C-0097
Study Start Date: December 18, 2001
Record last reviewed: November 18, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029094
Other Sarcoma Studies:
1. Temozolomide and O6-Benzylguanine for Treating Childhood Cancers
2. Treating Inoperable Lung Tumors With Heated Chemotherapy Medicine Delivered Solely to the Lung
3. Late Effects of Treatment for Sarcomas in Children
4. A Pilot Study for the Treatment of Patients with Metastatic and High Risk Sarcomas and Primitive Neuroectodermal Tumors
5. Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas
Related Studies:
Other Sarcoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase II Trial of Gleevec (STI571) in Patients with Advanced Soft Tissue or Bone Cancer
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