A Phase 1/2 interventional study of filgrastim and rituximab in Lymphoma, sponsored by Cancer Research UK. Withdrawn at 5 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-26.
Sponsored by Cancer Research UK · Phase 1/2, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
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DISEASE CHARACTERISTICS:
Histologically confirmed, CD20+, diffuse large B-cell lymphoma (DLBCL) according to WHO lymphoma classification
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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
This study is withdrawn, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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