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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)

Phase 1/Phase 2
18 Years
Open (Enrolling)

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Trial Information

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)



- 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

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.

Inclusion Criteria


- Histologically confirmed, CD20+, diffuse large B-cell lymphoma (DLBCL) according to
WHO lymphoma classification

- Histological transformation of a previously known indolent lymphoma allowed

- Biopsy-proven DLBCL arising from an indolent lymphoma not diagnosed previously

- Disease in first relapse after complete remission, partial response (PR), or less
than a PR after first-line of treatment

- No primary CNS lymphoma


- ECOG performance status 0-2

- Life expectancy > 3 months

- Serum creatinine < 150 μmol/L

- Serum bilirubin < 35 μmol/L

- Transaminases < 2.5 times upper limit of normal (unless attributed to lymphoma)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No contraindication to any of the drugs contained in the immunochemotherapy regimen

- No other malignancy within the past 2 years, except basal cell or squamous cell
carcinoma of the skin or carcinoma in situ of the cervix

- No other serious active disease that, in the opinion of the investigator, would
preclude the patient from having conventional chemotherapy

- No HIV positivity

- No medical or psychiatric conditions that compromise the patient's ability to give
informed consent


- Not specified

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity and maximum tolerated dose of Se-methyl-seleno-L-cysteine (MSC) (Phase I)

Safety Issue:


Principal Investigator

Silvia Montoto, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barts and the London NHS Trust



Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse