Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma

NCT00027716 | Completed Phase 2

• 3 other identifiers: 01-073CDR0000069060NCI-1757
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Sarcoma

Keywords

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

Interventions

bortezomib DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Chicago Cancer Research Center

New York, New York, 10021, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Abramson Cancer Center at University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Myosarcoma; Neoplasms, Muscle Tissue; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert Maki, MD, PhD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: October 1, 2001
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: June 6, 2013

Record last verified: 2013-06

Locations

US (6)