Status:
WITHDRAWN
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
Lead Sponsor:
Cancer Research UK
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 t...
Detailed Description
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)...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00829205
Start Date
January 1 2009
Last Update
August 26 2013
Active Locations (5)
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1
Barts and the London NHS Trust
London, England, United Kingdom, EC1A 7BE
2
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
3
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
4
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH