Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE) Followed by Gallium Nitrate, Rituximab and Dexamethasone (GARD) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
|ClinicalTrials.gov Identifier: NCT00836173|
Recruitment Status : Withdrawn (Gallium is no longer available for the conduct of this study.)
First Posted : February 4, 2009
Last Update Posted : March 16, 2016
The purpose of this study is to find out what effects, good and/or bad; rituximab, ifosfamide, carboplatin and etoposide (RICE) followed by gallium nitrate, rituximab and dexamethasone (GARD) have on diffuse large B cell lymphoma.
This research is being done to try to find a more effective treatment for this type of cancer. We want to know whether treatment with rituximab, ifosfamide, carboplatin and etoposide (RICE) then followed by gallium nitrate, rituximab and dexamethasone (GARD) will improve survival.
Rituximab, ifosfamide, carboplatin and etoposide (RICE) are part of the usual treatment for diffuse large B-cell lymphoma.
Gallium nitrate, rituximab and dexamethasone (GARD) in lymphoma is experimental.
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma||Drug: RICE Drug: GaRD Treatment||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Evaluating Three Cyslces of Ifosfamide, Carboplatin, Etoposide, and Rituximab (RICE) Followed by Two Cycles of Gallium Nitrate, Rituximab and Dexamethasone (GARD) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma MA|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: RICE followed by GARD
RICE treatment: Rituximab by intravenous infusion over 6-8 hours on day 1, Eptoposide by intravenous infusion over 2 hours on day 3-5, a 1-hour infusion of Carboplatin on day 4 and a 24-hour infusion of Ifosfamide on day 4, each cycle is 14 days (2 weeks). Patients will receive 3 cycles of RICE treatment.Drug: GaRD Treatment
After RICE treatment, patients will have gallium nitrate IV through a vein continuously over a 7 day period. Patients will also receive rituximab by intravenous infusion over a 3-6 hour period on day 1 of each cycle. Dexamethasone will be given as pills to be taken for 4 days in a row on the first 4 days of each cycle. The length of each cycle is 21 days (3 weeks). All patients will have 2 cycles of GaRD.
- To determine CR rates of standard salvage chemotherapy with rituximab, ifosfamide, carboplatin and etoposide (RICE) for relapsed/refractory diffuse aggressive NHL followed by a novel regimen of gallium nitrate, rituximab, and dexamethasone (GARD) [ Time Frame: 12 weeks ]
- To determine progression-free survival and overall survival following an autologous stem cell transplant performed after the completion of the above regimen, as well as assessment of stem cell collection. [ Time Frame: 18 months ]
- To determine the toxicities of the regimen [ Time Frame: approximately 12 weeks ]
- To investigate in vitro assays that may predict response to gallium based salvage chemotherapy [ Time Frame: 18 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836173
|United States, Illinois|
|Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center|
|Maywood, Illinois, United States, 60153|
|Principal Investigator:||Scott Smith, MD, PhD, FACP||Loyola University|