Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
|ClinicalTrials.gov Identifier: NCT00003397|
Recruitment Status : Completed
First Posted : April 30, 2004
Last Update Posted : September 24, 2009
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: filgrastim Biological: rituximab Biological: sargramostim Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: dexamethasone Drug: etoposide Drug: gemcitabine hydrochloride Drug: melphalan Drug: paclitaxel Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation||Phase 2|
OBJECTIVES: I. Evaluate the 1 and 2 year event free survival of patients with poor prognosis, relapsed or refractory intermediate or high grade B-cell non-Hodgkin's lymphoma who receive high dose carmustine and melphalan plus gemcitabine followed by rituximab (IDEC-C2B8 monoclonal antibody; anti-CD20 monoclonal antibody) plus sargramostim and consolidation chemotherapy with alternating dexamethasone/cyclophosphamide/ etoposide/cisplatin plus gemcitabine and paclitaxel/cisplatin and compare these figures to a historical control population. II. Evaluate the ability of posttransplant rituximab therapy in combination with sargramostim (GM-CSF) to control and further treat residual lymphoma remaining after high dose therapy in these patients. III. Evaluate quality of life parameters and assess the risk of secondary malignancies following this treatment regimen in these patients.
OUTLINE: Patients receive high dose gemcitabine IV over 100 minutes on day -5 and again approximately 6 hours after carmustine IV over 2 hours on day -2. On day -1, patients receive melphalan IV over 20 minutes followed 24 hours later (day 0) with peripheral blood stem cells transplantation. Patients then receive sargramostim (GM-CSF) subcutaneously beginning on day 4 until granulocyte count is greater than 1,000/mm3 for 2 consecutive days. At weeks 5-8 posttransplant, patients receive rituximab (IDEC-C2B8 monoclonal antibody; anti-CD20 monoclonal antibody) IV over 3-4 hours weekly. Prior to rituximab treatment at week 4 posttransplant, patients receive sargramostim (GM-CSF) subcutaneously 3 times a week continuing through rituximab therapy. At approximately 3 and 9 months posttransplant, patients receive dexamethasone orally every day for days 1-4, and cyclophosphamide, etoposide, and cisplatin by continuous infusion for 4 days (days 1-4), and gemcitabine IV over 100 minutes on days 1 and 5. At approximately 6 and 12 months posttransplant, patients receive paclitaxel IV over 6 hours on day 2 and cisplatin IV over 24 hours on day 3. Patients are followed at least every 6 weeks to 3 months until death.
PROJECTED ACCRUAL: An estimated 25 patients per year will be accrued into this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Official Title:||Autologous Stem Cell Transplantation for Poor Prognosis, Relapsed, or Refractory Intermediate-High Grade B-Cell Lymphoma Using Gemcitabine Plus High Dose BCNU and Melphalan Followed by Anti-CD20 Moab (IDEC C2B8, Rituximab, Rituxan) and Consolidative Chemotherapy|
|Study Start Date :||September 1998|
|Actual Primary Completion Date :||December 2002|
|Actual Study Completion Date :||December 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003397
|United States, Maryland|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland|
|Baltimore, Maryland, United States, 21201|
|Study Chair:||Aaron P. Rapoport, MD||University of Maryland Greenebaum Cancer Center|