Non-Hodgkin's LymphomaPhase 2NCT00504751
Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL
A Phase 2 study testing bortezomib, dexamethasone, ifosfamide and mesna, cisplatin, etoposide, rituximab in people with Non-Hodgkin's Lymphoma, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Objectives The primary objective of this study is to: determine the complete and partial response rates and the toxicity profile of bortezomib (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus rituximab (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- bortezomib, dexamethasone, ifosfamide and mesna, cisplatin, etoposide, rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to 17 Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Histologically confirmed diagnosis of CD20 positive, diffuse large B-cell NHL; de novo or transformed histologies are acceptable
- Patient must have relapsed after or not responded to at least one standard, upfront multi-agent chemotherapy for DLBCL
- Measurable PET positive disease, as defined by tumor mass > 1.5 cm in one dimension
- Stage II, III, or IV disease
- Age > 18 years
- Adequate liver and kidney function (total bilirubin < 2 x ULN and creatinine < 2.0 mg/dl, unless abnormalities are related to lymphoma or Gilbert's disease
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- Adequate bone marrow reserves (absolute neutrophil count >1500 cells/mm3 and platelet count > 100,000, unless cytopenias are the result of marrow infiltration by lymphoma
- ECOG performance status < 2
- Life expectancy of at least 3 months
- Bortezomib-naive
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
Who cannot join
- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), 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.
- Patient has hypersensitivity to boron or mannitol
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. (Pregnancy testing is not required for post-menopausal or surgically sterilized women)
- Patient has received other investigational drugs or cytotoxic chemotherapy within 14 days of enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
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- Known HIV infection
- Active Hepatitis B or C as defined by positive Hepatitis B surface antigen or hepatitis C RNA
- Known CNS disease
- Pregnant or nursing women
- Concurrent treatment with other chemotherapy or anti-lymphoma therapy, including corticosteroids, unless on a stable dose of corticosteroids less than the equivalent of 20 mg of prednisone each day for treatment of disease not related to lymphoma
- Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- Any condition that, in the opinion of the investigator, would prevent the subject from being fully compliant with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
Official title: Phase II Trial of "VIPER" Chemotherapy in Relapsed and Refractory Diffuse Large B-cell Lymphoma (NHL)
Objectives
The primary objective of this study is to:
Read more
- determine the complete and partial response rates and the toxicity profile of bortezomib (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus rituximab (i.e. VIPER) to patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma
The secondary objectives of this study are to:
- assess event free survival and overall survival
- assess conversion of chemo-resistant to chemo-sensitive disease
- assess the ability to collect stem cells from patients treated with salvage VIPER who then undergo autologous stem cell transplantation
- perform correlative studies on pre-treatment tumor biopsy specimens; analyses will include the assessment of immunohistochemical expression patterns (germinal center B cell vs. activated B cell) and NF-κB activity
Read the detailed description
Single arm phase II trial of combination therapy bortezomib, DICE, and Rituximab in patients with relapsed and refractory diffuse large B-cell non-Hodgkin's lymphoma (NHL)
VIPER chemotherapy will be administered every 28 days at the following doses:
- Dexamethasone 40 mg IV days 1-4
- Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
- Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
- Cisplatin 25 mg IV days 1-4
- Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
- Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
- VELCADE 1.5 mg/m2 on days 2 and 5
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- bortezomib, dexamethasone, ifosfamide, mesna, cisplatin, etoposide, rituximab
- Keywords
- diffuse large b cell
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomib, dexamethasone, ifosfamideDrug
VIPER chemotherapy will be administered every 28 days at the following doses:
- Dexamethasone 40 mg IV days 1-4
- Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
- Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
- Cisplatin 25 mg IV days 1-4
- Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
- Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
- VELCADE 1.5 mg/m2 on days 2 and 5
mesna, cisplatin, etoposide, rituximabDrug
VIPER chemotherapy will be administered every 28 days at the following doses:
- Dexamethasone 40 mg IV days 1-4
- Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
- Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
- Cisplatin 25 mg IV days 1-4
- Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
- Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
- VELCADE 1.5 mg/m2 on days 2 and 5
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment | Experimental | This is a single arm study Receives: Drug: bortezomib, dexamethasone, ifosfamide; Drug: mesna, cisplatin, etoposide, rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response
Complete Response
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2010
- Study completion17 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Richard Furman, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504751
- Sponsor's protocol ID
- 0701008963
- Status last verified
- Feb 2017
- First submitted
- 19 Jul 2007
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of "VIPER" Chemotherapy in Relapsed and Refractory Diffuse Large B-cell Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT00504751
- Acronym / sponsor ID
- 0701008963
- Conditions
- Non-Hodgkin's Lymphoma
- Keywords
- diffuse large b cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- May 2007 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- 17 Feb 2012 (actual)
- First posted
- 20 Jul 2007 (estimated)
- Results
- Posted 7 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives
The primary objective of this study is to:
- determine the complete and partial response rates and the toxicity profile of bortezomib (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus rituximab (i.e. VIPER) to patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma
The secondary objectives of this study are to:
- assess event free survival and overall survival
- assess conversion of chemo-resistant to chemo-sensitive disease
- assess the ability to collect stem cells from patients treated with salvage VIPER who then undergo autologous stem cell transplantation
- perform correlative studies on pre-treatment tumor biopsy specimens; analyses will include the assessment of immunohistochemical expression patterns (germinal center B cell vs. activated B cell) and NF-κB activity
Detailed description
Single arm phase II trial of combination therapy bortezomib, DICE, and Rituximab in patients with relapsed and refractory diffuse large B-cell non-Hodgkin's lymphoma (NHL)
VIPER chemotherapy will be administered every 28 days at the following doses:
- Dexamethasone 40 mg IV days 1-4
- Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
- Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
- Cisplatin 25 mg IV days 1-4
- Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
- Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
- VELCADE 1.5 mg/m2 on days 2 and 5
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Treatment | Experimental | Drug: bortezomib, dexamethasone, ifosfamide, Drug: mesna, cisplatin, etoposide, rituximabThis is a single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed diagnosis of CD20 positive, diffuse large B-cell NHL; de novo or transformed histologies are acceptable
- Patient must have relapsed after or not responded to at least one standard, upfront multi-agent chemotherapy for DLBCL
- Measurable PET positive disease, as defined by tumor mass > 1.5 cm in one dimension
- Stage II, III, or IV disease
- Age > 18 years
Key exclusion criteria (13 listed)
- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), 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.
- Patient has hypersensitivity to boron or mannitol
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. (Pregnancy testing is not required for post-menopausal or surgically sterilized women)
- Patient has received other investigational drugs or cytotoxic chemotherapy within 14 days of enrollment
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 |
|---|---|---|
| bortezomib, dexamethasone, ifosfamideVIPER chemotherapy will be administered every 28 days at the following doses: * Dexamethasone 40 mg IV days 1-4 * Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4 * Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide) * Cisplatin 25 mg IV days 1-4 * Etoposide 100 mg/m2 CIVI over 24 hours days 1-4 * Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles) * VELCADE 1.5 mg/m2 on days 2 and 5 | Drug | Study Treatment |
| mesna, cisplatin, etoposide, rituximabVIPER chemotherapy will be administered every 28 days at the following doses: * Dexamethasone 40 mg IV days 1-4 * Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4 * Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide) * Cisplatin 25 mg IV days 1-4 * Etoposide 100 mg/m2 CIVI over 24 hours days 1-4 * Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles) * VELCADE 1.5 mg/m2 on days 2 and 5 | Drug | Study Treatment |
Primary outcome
Complete Response
Time frame: 26 months
Complete Response
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Furman, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bortezomib, dexamethasone, ifosfamide and mesna, cisplatin, etoposide, rituximab in people with Non-Hodgkin's Lymphoma, run by Weill Medical College of Cornell University 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 13 inclusion and 13 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: finished, as of the sponsor's last update on 7 Apr 2017. 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?
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?
Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Response (time frame: 26 months). 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 7 Apr 2017.