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Home > "T" Clinical Trials Conditions > Trastuzumab in Treating Patients With Recurrent Osteosarcoma  Trastuzumab in Treating Patients With Recurrent Osteosarcoma
Trastuzumab in Treating Patients With Recurrent Osteosarcoma
For Condition: recurrent osteosarcoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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 recurrentosteosarcoma.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulMeyers, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Paul Meyers 212-639-5952
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Najat Daw 901-495-2573
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Judith Sato 626-930-5430
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Holcombe Grier 617-632-3971
Additional Information:
Study ID Numbers: CDR0000067558; MSKCC-99097,NCI-T98-0083
Study Start Date:
Record last reviewed: September 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005033
Other Recurrent Osteosarcoma Studies:
1. Inhaled Sargramostim in Treating Patients With First Pulmonary (Lung) Recurrence of Osteosarcoma
2. Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma
3. Trastuzumab in Treating Patients With Recurrent Osteosarcoma
4. Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma or Ewing's Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma
5. Docetaxel in Treating Children With Recurrent Solid Tumors
Related Studies:
Other recurrent osteosarcoma Clinical Trials
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Other Memphis Clinical Trials
Trastuzumab in Treating Patients With Recurrent Osteosarcoma
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