Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma

• Status: Completed
• Trial end date: 2004-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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 metastatic sarcoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib

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