Expired Study
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New York, New York 10021


Purpose:

RATIONALE: Drugs used in chemotherapy, such as cisplatin, doxorubicin, and methotrexate, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pamidronate with chemotherapy may prevent bone metastases and reduce the chance of bone replacement problems by strengthening bones in patients who are undergoing surgery for osteosarcoma. PURPOSE: Phase II trial to study the effectiveness of combining neoadjuvant and adjuvant pamidronate with induction and maintenance chemotherapy in treating patients who have newly diagnosed osteosarcoma.


Study summary:

OBJECTIVES: - Determine the safety and feasibility of pamidronate with standard induction and maintenance chemotherapy in patients with newly diagnosed high-grade osteosarcoma. - Determine the frequency of favorable tumor necrosis produced in patients treated with this regimen. - Determine the event-free survival of patients without metastatic disease at presentation treated with this regimen. - Determine the prosthesis failure-free survival of patients treated with this regimen and who ultimately undergo limb preservation surgery with insertion of an endoprosthesis. OUTLINE: Patients are stratified according to extent of disease (localized vs metastatic). - Induction therapy: Patients receive standard chemotherapy comprising cisplatin IV over 4 hours and doxorubicin IV over 15-30 minutes on weeks 0 and 5 and high-dose methotrexate IV over 4 hours on weeks 3, 4, 8, and 9. Patients also receive pamidronate IV over 2-4 hours beginning approximately 3 days after initiation of chemotherapy on week 0 and repeating once every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. - Surgery*: Patients undergo surgical resection of primary tumor on week 10 and then proceed to maintenance therapy. Patients with metastatic disease undergo further surgery of metastatic sites after recovery from definitive resection of the primary tumor before proceeding to maintenance therapy. NOTE: *Patients who have undergone definitive surgical resection before study entry may proceed to maintenance therapy or, if appropriate, surgical resection of metastatic disease - Maintenance therapy: Patients receive standard chemotherapy comprising cisplatin IV over 4 hours on weeks 0 and 5; doxorubicin IV over 15-30 minutes on weeks 0, 5, 10, and 15; and high-dose methotrexate IV over 4 hours on weeks 3, 4, 8, 9, 13, 14, 18, and 19. Patients also receive pamidronate as in induction therapy for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 1 year. PROJECTED ACCRUAL: A total of 75 patients (50 with localized disease; 25 with metastatic disease) will be accrued for this study within 3-4 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed high-grade osteosarcoma - Newly diagnosed - Previously untreated - Prior definitive surgical resection of primary tumor allowed - No history of Paget's disease PATIENT CHARACTERISTICS: Age - Any age Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Platelet count at least 100,000/mm^3 - Absolute neutrophil at least 1,000/mm^3 Hepatic - AST no greater than 3 times upper limit of normal (ULN) - Bilirubin no greater than 1.5 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - Shortening fraction at least 28% by echocardiogram OR - Ejection fraction at least 50% by radionuclide angiogram - No history of pericarditis or myocarditis - No history of symptomatic arrhythmia - No history of symptomatic cardiac conduction abnormalities Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No history of other cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy Surgery - See Disease Characteristics Other - No prior treatment for cancer - No concurrent enrollment on another therapeutic study


NCT ID:

NCT00072306


Primary Contact:

Principal Investigator
Paul A. Meyers, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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