Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00003957|
Recruitment Status : Completed
First Posted : August 5, 2004
Last Update Posted : April 17, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have relapsed non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: filgrastim Biological: recombinant human stem cell factor Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: melphalan Drug: mitoxantrone hydrochloride Drug: paclitaxel Procedure: peripheral blood stem cell transplantation||Phase 2|
OBJECTIVES: I. Determine how many patients with chemotherapy sensitive relapsed non-Hodgkin's lymphoma receiving sequential high dose chemotherapy achieve a collection of a minimum 5 million CD34+ cells/kg in one large volume apheresis. II. Determine the feasibility and safety of this regimen in these patients. III. Determine disease free and overall survival of patients receiving this regimen.
OUTLINE: Patients receive cyclophosphamide IV over 1 hour followed by paclitaxel IV over 24 hours on day 1. Filgrastim (G-CSF) and stem cell factor (SCF) are administered subcutaneously beginning on day 3 for approximately 7-14 days (until the completion of leukapheresis). Peripheral blood stem cells (PBSC) are collected over 3-5 days. Three weeks after leukapheresis is completed, patients receive cytarabine IV over 2 hours twice a day on days -6 to -3. Mitoxantrone IV is administered over 1 hour on day -6. CD34+ PBSC are reinfused on day 0. Four weeks later, patients receive etoposide IV over 11 hours on day -2 and melphalan IV over 30 minutes twice on day -1. CD34+ PBSC are reinfused on day 0. Concurrent G-CSF is administered subcutaneously and continues until blood counts recover. Patients are followed at 4 weeks, every 3 months for the first 2 years, and then every 6 months for the next 2 years.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Official Title:||A Phase II Trial of Multiple Cycles of Sequential High Dose Chemotherapy for Patients With Chemotherapy Sensitive Relapsed Non-Hodgkin's Lymphoma|
|Study Start Date :||December 1998|
|Primary Completion Date :||September 2000|
|Study Completion Date :||August 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003957
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Study Chair:||Russell J. Schilder, MD||Fox Chase Cancer Center|