- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00836173
Rituximab, Ifosfamide, Carboplatin, and Etoposide (RICE) Followed by Gallium Nitrate, Rituximab and Dexamethasone (GARD) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RICE followed by GARD
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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18 months
|
To determine the toxicities of the regimen
Time Frame: approximately 12 weeks
|
approximately 12 weeks
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To investigate in vitro assays that may predict response to gallium based salvage chemotherapy
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott Smith, MD, PhD, FACP, Loyola University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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