Se-Methyl-Seleno-L-Cysteine, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Diffuse Large B-Cell Lymphoma That Has Relapsed or Not Responded to Treatment
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|ClinicalTrials.gov Identifier: NCT00829205|
Recruitment Status : Withdrawn
First Posted : January 26, 2009
Last Update Posted : August 26, 2013
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer cell growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer cell-killing substances to them. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Se-methyl-seleno-l-cysteine may help reduce the side effects of chemotherapy.
PURPOSE: This phase I/II trial is studying the side effects and best dose of Se-methyl-seleno-l-cysteine when given together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well it works in treating patients with diffuse large B-cell lymphoma that has relapsed or not responded to treatment.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: filgrastim Biological: rituximab Dietary Supplement: Se-methyl-seleno-L-cysteine Drug: carboplatin Drug: etoposide Drug: ifosfamide Other: laboratory biomarker analysis Other: pharmacological study||Phase 1 Phase 2|
- To assess dose-limiting toxicity and maximum-tolerated dose (MTD) of Se-methyl-seleno-L-cysteine (MSC) (to achieve a trough serum selenium [Se] concentration of > 20 μmol/L) prior to and in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in patients with relapsed or refractory diffuse large B-cell lymphoma. (Phase I)
- To determine the overall response rate to R-ICE given in addition to MSC at the MTD in these patients. (Phase II)
- To determine the toxicity of R-ICE when used in combination with MSC in these patients.
- To determine the effect of MSC dosing on serum and intracellular Se and Se species in these patients.
- To determine the pharmacokinetics of MSC after single and multiple daily dosing in these patients.
- To investigate the effect of MSC dosing on Se-dependent processes (e.g., NFκB activity and AKT).
OUTLINE: This is a multicenter, phase I, dose-escalation study of Se-methyl-seleno-L-cysteine (MSC) followed by a phase II study.
Patients receive rituximab IV on day 1, carboplatin IV on day 2, ifosfamide IV and etoposide IV on days 2-4 (R-ICE), and filgrastim (G-CSF) subcutaneously on days 6-13. Patients also receive oral MSC twice daily on days -7 to 0 and once daily in courses 1-2. Treatment with R-ICE and G-CSF repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically and analyzed for pharmacokinetics and protein markers.
After completion of study treatment, patients are followed monthly for 3 months.
This study is peer reviewed and funded or endorsed by cancer research UK.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Methylselenocysteine (MSC) in Combination With Immunochemotherapy (R-ICE) in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)|
|Study Start Date :||January 2009|
- Dose-limiting toxicity and maximum tolerated dose of Se-methyl-seleno-L-cysteine (MSC) (Phase I)
- Overall response rate (Phase II)
- Toxicity as assessed by NCI CTCAE v 3.0
- Serum and intracellular Se and Se species
- Pharmacokinetics of MSC
- Protein markers of selenium activity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829205
|Barts and the London NHS Trust|
|London, England, United Kingdom, EC1A 7BE|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Manchester, England, United Kingdom, M20 4BX|
|Plymouth, England, United Kingdom, PL6 8DH|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Principal Investigator:||Silvia Montoto, MD||Barts and the London NHS Trust|