Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE) Followed by Gallium Nitrate, Rituximab and Dexamethasone (GARD) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This study is currently recruiting participants.
Verified September 2011 by Loyola University

First Received on February 3, 2009.  
Last Updated on September 13, 2011  
History of Changes
This Clinical Trial Sponsored By: Loyola University
Collaborator: Genta Incorporated
Information provided by (Responsible Party): Loyola University
ClinicalTrials.gov Identifier: NCT00836173
 

Purpose for Clinical Trial

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 Study Intervention Clinical Trial Phase
Diffuse Large B-cell Lymphoma Drug: RICE
Drug: GaRD Treatment
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Lymphoma
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone Sodium Phosphate
Ifosfamide
Gallium nitrate
Etoposide
Carboplatin
Etoposide phosphate
Rituximab

U.S. FDA Resources

Further study details as provided by Loyola University:

Primary Outcome Measures For Clinical Trial:

  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • 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 ] [ Designated as safety issue: No ]
  • To determine the toxicities of the regimen [ Time Frame: approximately 12 weeks ] [ Designated as safety issue: Yes ]
  • To investigate in vitro assays that may predict response to gallium based salvage chemotherapy [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Study Intervention Details:

    Drug: RICE

    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.

Detailed Description:

This is a Phase 2 trial evaluating the efficacy of adding the combination of GaRD x 2 cycles following 3 cycles of the standard salvage regimen of RICE for the treatment of relapsed or refractory diffuse, large B-cell lymphoma (DLBCL). The study will include patients who have relapsed after 1 prior treatment regimen or who are refractory to initial chemotherapy. We will evaluate patients for response rate (both partial and complete), toxicities, as well as overall and progression free survival. Eligible patients will receive standard RICE x 3 cycles followed by GaRD x 2 cycles. Patients who would otherwise be eligible, may then proceed to autologous stem cell transplant (ASCT).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have histologically or cytologically confirmed diffuse, large B-cell lymphoma (WHO classification diffuse large B-cell lymphoma or mediastinal large B-cell lymphoma), immunoblastic B cell lymphoma or Burkitts lymphoma. Transformed, large B-cell lymphoma will be excluded.
  • Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm with spiral CT scan.
  • Must be refractory to initial therapy or have disease relapse from prior therapy and must be at least 3 weeks post treatment from prior chemotherapy or radiation therapy.
  • Age >18 years.
  • Life expectancy >24 weeks
  • SWOG performance status <1 (Karnofsky >80%).
  • Must have normal organ function (or i

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