Know Cancer

or
forgot password

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


Phase 2
N/A
N/A
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul A. Meyers, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067558

NCT ID:

NCT00005033

Start Date:

December 1999

Completion Date:

August 2004

Related Keywords:

  • Sarcoma
  • recurrent osteosarcoma
  • Osteosarcoma
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
City of Hope Comprehensive Cancer CenterDuarte, California  91010