NCT00829205

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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

5 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
Last Updated

August 26, 2013

Status Verified

July 1, 2009

First QC Date

January 23, 2009

Last Update Submit

August 23, 2013

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (2)

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

  • Overall response rate (Phase II)

Secondary Outcomes (4)

  • Toxicity as assessed by NCI CTCAE v 3.0

  • Serum and intracellular Se and Se species

  • Pharmacokinetics of MSC

  • Protein markers of selenium activity

Interventions

filgrastimBIOLOGICAL
rituximabBIOLOGICAL
Se-methyl-seleno-L-cysteineDIETARY_SUPPLEMENT
carboplatinDRUG
etoposideDRUG
ifosfamideDRUG
laboratory biomarker analysisOTHER
pharmacological studyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

Barts and the London NHS Trust

London, England, EC1A 7BE, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, Diffuse

Interventions

FilgrastimRituximabselenomethylselenocysteineCarboplatinEtoposideIfosfamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Silvia Montoto, MD

    Barts and the London NHS Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 26, 2009

Study Start

January 1, 2009

Last Updated

August 26, 2013

Record last verified: 2009-07

Locations

GB(5)