Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy and peripheral stem cell transplantation in treating patients who have advanced or recurrent sarcoma.
Drug: doxorubicin hydrochloride
Procedure: peripheral blood stem cell transplantation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||High-Dose Doxorubicin and Ifosfamide Followed by Melphalan and Cisplatin for Patients With High-Risk and Recurrent Sarcoma|
- Evaluate the feasibility of administration of two cycles of high-dose chemotherapy followed by autologous stem cell support in patients with high-risk or advanced sarcomas. [ Time Frame: 2 years after completion of treatment ] [ Designated as safety issue: No ]
- Evaluate the toxicities of two cycles of sequential high-dose chemotherapy with autologous stem cell support. [ Time Frame: 2 months after completion of second cycle of treatment. ] [ Designated as safety issue: Yes ]
- Evaluate the effectiveness of sequential high-dose chemotherapy followed by autologous stem cell support in patients with high-risk or advanced sarcoma for response, disease-free survival and overall survival. [ Time Frame: Two years after completion of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||September 1994|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the feasibility of sequential high-dose chemotherapy with ifosfamide and doxorubicin followed by melphalan and cisplatin, each followed by autologous peripheral blood stem cell support, in patients with high-risk or advanced sarcomas. II. Determine the toxic effects of this regimen in these patients. III. Determine response rate and disease-free and overall survival in these patients treated with this regimen.
OUTLINE: Beginning at least 4 weeks prior to the start of chemotherapy, patients receive filgrastim (G-CSF) subcutaneously daily until the completion of peripheral blood stem cell (PBSC) harvesting. Beginning 5 days after the start of G-CSF, PBSCs are collected over several days. Patients who do not mobilize sufficient cells undergo bone marrow harvest. Regimen A: Patients receive high-dose ifosfamide IV and doxorubicin IV continuously over 96 hours on days -8 to -4. 12.5% of PBSCs or bone marrow are reinfused on day -2 and 37.5% are reinfused on day 0. Patients receive G-CSF IV beginning on day 0 and continuing until blood counts recover. Regimen B: Beginning at least 4 weeks after day 1 of Regimen A, patients receive high-dose melphalan IV followed immediately by cisplatin IV on days -11 and -4. Patients receive G-CSF IV on days -10 to -6. 12.5% of PBSCs or bone marrow are reinfused on day -3 and the remaining 37.5% are reinfused on day 0. Patients receive G-CSF IV beginning on day 0 and continuing until blood counts recover. Patients are followed monthly for 1 year, every 3 months for 1 year, and then as needed for 3 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002601
|United States, California|
|Cancer Center and Beckman Research Institute, City of Hope|
|Duarte, California, United States, 91010-3000|
|Study Chair:||George Somlo, MD||Beckman Research Institute|