Lymphoma, B-CellEarly Phase 1NCT00515138
A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant
A Early Phase 1 study testing Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib in people with Lymphoma, B-Cell, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study seeks to determine the maximum tolerated dose of bortezomib in combination with rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary refractory aggressive B-Cell Non-Hodgkin's lymphoma (diffuse large B-cell, mantle cell, follicular grade III, transformed lymphoma). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Nov 2011
- Phase
- Early Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aggressive B-Cell Lymphoma, CD-20 positive, in first relapse or refractory to first-line chemotherapy
- Diffuse large B-cell Lymphoma, Mantle cell lymphoma, Follicular lymphoma (Grade III), Transformed Follicular Lymphoma
- Rituximab is allowed
- Prior radiation is allowed
- 18-70 years of age
- ECOG performance status of 0-2
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- HIV seronegative
- Measurable disease on CT scan by international working group response criteria
- No CNS involvement
- Subject is considered to be a candidate for autologous stem cell transplant in the opinion of the treating physician
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
- Male subject agrees to use an acceptable method of contraception for the duration of the study
Who cannot join
- Platelet count of <75 x 10(9)/L
- Absolute neutrophil count of <1.0 x 10(9)/L
- Calculated or measured creatinine clearance of <60 mL/minute within 14 days before enrollment
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Subject has hypersensitivity to bortezomib, boron or mannitol.
- Female subject is pregnant or breast-feeding.
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- Subject has been treated with more than one prior chemotherapy regimen.
- Subject has received other investigational drugs with 14 days before enrollment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
This study seeks to determine the maximum tolerated dose of bortezomib in combination with rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary refractory aggressive B-Cell Non-Hodgkin's lymphoma (diffuse large B-cell, mantle cell, follicular grade III, transformed lymphoma). Subjects will be enrolled in cohorts of 3 at each bortezomib dose level, starting at 1 mg/m(2), and escalating to 1.3, 1.5, and 1.7 mg/m(2). Bortezomib will be given on days 1 (prior to rituximab) and 4, rituximab 375 mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6.
- Conditions
- Lymphoma, B-Cell
- Being tested
- Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib
- Keywords
- B-Cell NHL, Autologous Stem Cell Transplant, RICE
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab, Ifosfamide, Carboplatin, Etoposide, BortezomibDrug
Bortezomib starting at 1 mg/m(2), and escalating to 1.3, 1.5, 1.7. Bortezomib will be given on Days 1 (prior to rituximab) and 4, rituximab at 375 mg/m(2) on day 1, carboplatin AUC 5 and ifosfamide with mesna, each 5 mg/m(2), on day 3 and etoposide 100 mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6
What is being measured
The primary outcome is the main question the study is designed to answer.
-Determine the maximum tolerated dose of bortezomib in combination with rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary refractory aggressive B-cell NHL
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Investigator left institution. 7 patients accrued and there is insufficient data to analyze.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence D. Kaplan, M.D., Principal investigator, University of California, San FranciscoCaroline Behler, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515138
- Sponsor's protocol ID
- UC-CC06253
- Status last verified
- Apr 2012
- First submitted
- 9 Aug 2007
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT00515138
- Acronym / sponsor ID
- UC-CC06253
- Conditions
- Lymphoma, B-Cell
- Keywords
- B-Cell NHL, Autologous Stem Cell Transplant, RICE
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left institution. 7 patients accrued and there is insufficient data to analyze.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 13 Aug 2007 (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.
This study seeks to determine the maximum tolerated dose of bortezomib in combination with rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary refractory aggressive B-Cell Non-Hodgkin's lymphoma (diffuse large B-cell, mantle cell, follicular grade III, transformed lymphoma). Subjects will be enrolled in cohorts of 3 at each bortezomib dose level, starting at 1 mg/m(2), and escalating to 1.3, 1.5, and 1.7 mg/m(2). Bortezomib will be given on days 1 (prior to rituximab) and 4, rituximab 375 mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aggressive B-Cell Lymphoma, CD-20 positive, in first relapse or refractory to first-line chemotherapy
- 18-70 years of age
- ECOG performance status of 0-2
- HIV seronegative
- Measurable disease on CT scan by international working group response criteria
Key exclusion criteria (9 listed)
- Platelet count of <75 x 10(9)/L
- Absolute neutrophil count of <1.0 x 10(9)/L
- Calculated or measured creatinine clearance of <60 mL/minute within 14 days before enrollment
- Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Subject has hypersensitivity to bortezomib, boron or mannitol.
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 |
|---|---|---|
| Rituximab, Ifosfamide, Carboplatin, Etoposide, BortezomibBortezomib starting at 1 mg/m(2), and escalating to 1.3, 1.5, 1.7. Bortezomib will be given on Days 1 (prior to rituximab) and 4, rituximab at 375 mg/m(2) on day 1, carboplatin AUC 5 and ifosfamide with mesna, each 5 mg/m(2), on day 3 and etoposide 100 mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6 | Drug | – |
Primary outcome
-Determine the maximum tolerated dose of bortezomib in combination with rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary refractory aggressive B-cell NHL
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Investigator left institution. 7 patients accrued and there is insufficient data to analyze.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
- UCSF Cancer CenterLink provided by the sponsor.
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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.
Lawrence D. Kaplan, M.D. principal investigator
University of California, San Francisco
Caroline Behler, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib in people with Lymphoma, B-Cell, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. 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: stopped early, as of the sponsor's last update on 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 stopped early (reason given: Investigator left institution. 7 patients accrued and there is insufficient data to analyze.). Results are not available in the source record.
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?
-Determine the maximum tolerated dose of bortezomib in combination with rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary refractory aggressive B-cell NHL (time frame: 3 years). 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 12 Apr 2012.