Se-Methyl-Seleno-L-Cysteine, Rituximab, Ifosfamide, Carboplatin, and Etopos... | Stopped
Se-Methyl-Seleno-L-Cysteine, Rituxi... | Stopped
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

Trial Source

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Medical Conditions
  • Lymphoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Stopped
Recruitment Status
NCT00829205
Primary Trial ID Number

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Summary
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.
Research Details
  • OBJECTIVES:

    Primary

    - 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)

    Secondary

    - 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.
Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Study Type
Interventional
Intervention
Biological : filgrastim, Biological : rituximab, Dietary Supplement : Se-methyl-seleno-L-cysteine, Drug : carboplatin, Drug : etoposide, Drug : ifosfamide, Other : laboratory biomarker analysis, Other : pharmacological study

Study Arm Groups : , , , , , , ,

Intervention Type
See Interventions above
Primary Outcome Measures
    Dose-limiting toxicity and maximum tolerated dose of Se-methyl-seleno-L-cysteine (MSC) (Phase I); null; Overall response rate (Phase II); null
Secondary Outcome Measures
    Toxicity as assessed by NCI CTCAE v 3.0; null; Serum and intracellular Se and Se species; null; Pharmacokinetics of MSC; null; Protein markers of selenium activity; null
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
    DISEASE CHARACTERISTICS:

    - 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 allowed

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

    - No primary CNS lymphoma

    PATIENT CHARACTERISTICS:

    - 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

    PRIOR CONCURRENT THERAPY:

    - Not specified
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
Southampton General Hospital
Southampton
England
SO16 6YD
London
EC1A 7BE
Plymouth
PL6 8DH
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific 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)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CDR0000632722
Sponsor(s)
Cancer Research UK
Key Dates

Recruitment Start Date

Jan 2009

Recruitment End Date
Date Not Available
Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

23 Jan 2009

Date updated in source

23 Aug 2013