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Home > "B" Clinical Trials Conditions > Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma  Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
For Condition: Osteosarcoma,metastatic tumors of the Ewing's family,adult soft tissue sarcoma,tumors of the Ewing's family,metastatic osteosarcoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have advanced or metastaticsarcoma.
Details: OBJECTIVES: - Determine the response rate in patients with advanced or metastatic sarcoma treated with bortezomib. - Correlate levels of cyclins D1, E, p21 (WAF1), p27 (Kip1), mdm^2, p53, and Ki67 with response in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease (stratum I: soft tissue sarcoma not specified in stratum II, osteogenic sarcoma arising from soft tissues, or gastrointestinal stromal tumor vs stratum II: Ewing's sarcoma of soft tissue or bone, rhabdomyosarcoma, or osteogenic sarcoma of bone). (Stratum I closed to accrual as of 10/17/03.) Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for stratum I within 5-11 months and 21-41 patients will be accrued for stratum II within 10.5-22 months. (Stratum I closed to accrual as of 10/17/03.)
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed sarcoma - Soft tissue metastasis or locally recurrent disease - Stratum I (closed to accrual as of 10/17/03): - Soft tissue sarcoma not specified in stratum II - Osteogenic sarcoma arising from soft tissue or gastrointestinal stromal tumor (GIST) - Stratum II: - Ewing's sarcoma of soft tissue or bone (if measurable soft tissue metastasis is present) - Rhabdomyosarcoma - Osteogenic sarcoma of bone (if measurable soft tissue metastasis is present) - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Disease progression within the past 3 months - No prior or active known brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 80-100% OR - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST/ALT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - No peripheral vascular disease requiring surgical management - No history of congestive heart failure even if it is medically controlled - No angina pectoris even if it is medically controlled - No myocardial infarction within the past year - No cardiac arrhythmias - No prior cerebrovascular event - No prior transient ischemic attack - No EKG evidence of acute ischemia or conduction abnormality (e.g., bifascicular block [left anterior hemiblock in the presence of right bundle branch block] or second or third degree atrioventricular block) - No history of orthostatic hypotension Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reaction to compounds of similar chemical or biological composition to study drug - No other uncontrolled concurrent illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance - No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix - No symptomatic peripheral neuropathy greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunotherapy and recovered - No concurrent biological or immunological agents Chemotherapy: - Stratum I (closed to accrual as of 10/17/03): - At least 1 year since prior chemotherapy in the adjuvant or neoadjuvant setting - No other prior chemotherapy - Stratum II: - No more than 1 prior chemotherapy regimen - No concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: - Not specified Other: - Prior imatinib mesylate for GIST (stratum I closed to accrual as of 10/17/03) allowed - No other concurrent investigational agents - No concurrent commercial anticancer agents or therapies - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMaki, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Gary Schwartz 212-639-8324
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting George Demetri 617-632-3985
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Peter O'Dwyer 215-662-8636
Albert Einstein College of Medicine *Recruiting*
Bronx, New York, 10461
United States
Recruiting Scott Wadler 718-904-2754
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Andrew Kraft 303-315-8802
University of Chicago Cancer Research Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Linda Skoog 212-639-2000
Additional Information:
Study ID Numbers: CDR0000069060; NCI-1757,MSKCC-01073
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027716
Other Metastatic Osteosarcoma Studies:
1. Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
Related Studies:
Other metastatic osteosarcoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
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