Trastuzumab in Treating Patients With Recurrent Osteosarcoma

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005033
• Other study ID #: CDR0000067558
• Secondary ID: MSKCC-99097NCI-T
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2000
• Last updated: June 20, 2013
• Start date: December 1999
• Est. completion date: August 2004

Study information

• Verified date: August 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteosarcoma
• Sarcoma

Intervention

Biological:
• trastuzumab

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,