Completed

Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma

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What is being tested

trastuzumab

+ conventional surgery

BiologicalProcedure
Who is being recruted

Neoplasms+4

+ Neoplasms by Histologic Type

+ Neoplasms, Connective Tissue

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 1999
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: June 21, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: Determine the response rate, freedom from progression, and survival of patients with recurrent osteosarcoma when treated with trastuzumab (Herceptin). Evaluate the toxicity of this drug in young patients with a history of osteosarcoma and prior therapy with doxorubicin. OUTLINE: This is a multicenter study. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes weekly. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity. After approximately 12 weeks of treatment, patients are evaluated for response and undergo surgical resection if clinically appropriate. Patients are followed for 1 year for survival. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 2 years.

NCT00005033
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: June 21, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueSarcomaOsteosarcoma

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

City of Hope Comprehensive Cancer Center

Duarte, United StatesOpen City of Hope Comprehensive Cancer Center in Google Maps

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

Boston, United States

Memorial Sloan-Kettering Cancer Center

New York, United States

St. Jude Children's Research Hospital

Memphis, United States
Completed4 Study Centers