Trastuzumab in Treating Patients With Recurrent Osteosarcoma

NCT00005033 | Completed Phase 2

• 3 other identifiers: CDR0000067558MSKCC-99097NCI-T98-0083
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have recurrent osteosarcoma.

Conditions

Sarcoma

Keywords

recurrent osteosarcoma

Interventions

trastuzumab BIOLOGICAL

conventional surgery PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed recurrent osteosarcoma after initial systemic therapy with doxorubicin * Measurable disease * Immunohistochemical evidence of 2+ overexpression of HER2 PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * ALT or AST less than 3 times upper limit of normal (ULN) * Bilirubin less than 1.5 times ULN Renal: * Creatinine less than 1.5 times ULN OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * Fractional shortening at least 29% by echocardiogram OR * Ejection fraction at least 50% by MUGA * No prior cardiac dysfunction, even if presently controlled Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * No prior anthracycline more than 450 mg/m\^2 Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No other concurrent cancer therapy

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 (4)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, 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

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

MeSH Terms

Conditions

Sarcoma; Osteosarcoma

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Paul A. Meyers, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: January 27, 2003
• Study Start: December 1, 1999
• Study Completion: August 1, 2004
• Last Updated: June 21, 2013

Record last verified: 2004-08

Locations

US (4)