Status:
WITHDRAWN
Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE) Followed by Gallium Nitrate, Rituximab and Dexamethasone (GARD) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Genta Incorporated
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
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 diff...
Eligibility Criteria
Inclusion
- 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 impaired marrow function) as defined below:
- leukocytes \> or equal to 1,500/mcL
- absolute neutrophil count \>or equal to 1,000/mcL
- platelets \>or equal to 50,000/mcL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT)\<or equal to 2.5 X institutional upper limit of normal unless due to lymphoma involvement
- creatinine clearance \> than or equal to 60 mL/min
- Must agree not to become pregnant for the duration of study participation.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
- Follicular B-cell lymphomas, small lymphocytic lymphomas, chronic lymphocytic leukemia, lymphoblastic lymphomas and all T-cell lymphomas.
- Patients may not be receiving any other investigational agents, within trials in the previous 4 weeks.
- Patients with known CNS metastases are excluded from this clinical trial.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to gallium nitrate, rituximab, dexamethasone, ifosfamide, carboplatin, and/or etoposide.
- Prior therapy with gallium nitrate, ifosfamide, carboplatin and/or etoposide
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and women who are nursing are excluded from this study.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with RICE and/or GaRD.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00836173
Start Date
July 1 2008
End Date
May 1 2012
Last Update
March 16 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center
Maywood, Illinois, United States, 60153