LymphomaPhase 1/2NCT00829205
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
A Phase 1/2 study testing filgrastim, rituximab and Se-methyl-seleno-L-cysteine in people with Lymphoma, run by Cancer Research UK at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- filgrastim, rituximab and Se-methyl-seleno-L-cysteine
- How many people
- 0 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Jan 2009to not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Barts and the London NHS Trust
London, England, EC1A 7BE
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Christie Hospital
Manchester, England, M20 4BX
Derriford Hospital
Plymouth, England, PL6 8DH
Southampton General Hospital
Southampton, England, SO16 6YD
About this study
Official 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)
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.
Read the 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) 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.
- Conditions
- Lymphoma
- Being tested
- filgrastim, rituximab, Se-methyl-seleno-L-cysteine, carboplatin, etoposide
- Keywords
- recurrent adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
rituximabBiological
Se-methyl-seleno-L-cysteineDietary supplement
carboplatinDrug
etoposideDrug
ifosfamideDrug
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- Silvia Montoto, MD, Principal investigator, Barts and the London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829205
- Sponsor's protocol ID
- CDR0000632722
- Other IDs
- CRUK-UCL-SelRICE, EUDRACT-2008-002678-36, EU-20902
- Status last verified
- Jul 2009
- First submitted
- 23 Jan 2009
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00829205
- Acronym / sponsor ID
- CDR0000632722
- Conditions
- Lymphoma
- Keywords
- recurrent adult diffuse large cell lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Jan 2009
- First posted
- 26 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim | Biological | – |
| rituximab | Biological | – |
| Se-methyl-seleno-L-cysteine | Dietary supplement | – |
| carboplatin | Drug | – |
| etoposide | Drug | – |
| ifosfamide | Drug | – |
| laboratory biomarker analysis | Other | – |
| pharmacological study | Other | – |
Primary outcome
Dose-limiting toxicity and maximum tolerated dose of Se-methyl-seleno-L-cysteine (MSC) (Phase I)
Overall response rate (Phase II)
4 secondary outcomes
Toxicity as assessed by NCI CTCAE v 3.0
Serum and intracellular Se and Se species
Pharmacokinetics of MSC
Protein markers of selenium activity
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Montoto, MD principal investigator
Barts and the London NHS Trust
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing filgrastim, rituximab and Se-methyl-seleno-L-cysteine in people with Lymphoma, run by Cancer Research UK at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity and maximum tolerated dose of Se-methyl-seleno-L-cysteine (MSC) (Phase I). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.