Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring metastatic osteosarcoma, recurrent adult soft tissue sarcoma, recurrent osteosarcoma, adult rhabdomyosarcoma, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, stage IV adult soft tissue sarcoma
Eligibility 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
Sites / Locations
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Albert Einstein College of Medicine
- Memorial Sloan-Kettering Cancer Center
- University of Chicago Cancer Research Center
- Abramson Cancer Center at University of Pennsylvania Medical Center