LymphomaPhase 1NCT00093704
Bortezomib and Ganciclovir in Treating Patients With Relapsed or Refractory Epstein Barr Virus-Positive Lymphoma
A Phase 1 study testing bortezomib + ganciclovir in people with Lymphoma and Lymphoproliferative Disorder, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Epstein Barr virus can cause cancer and lymphoproliferative disorders. Ganciclovir is an antiviral drug that acts against the Epstein Barr virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Lymphoproliferative Disorder
- What is being tested?
- bortezomib + ganciclovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jul 2010
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed Epstein Barr virus-positive lymphoma, including the following subtypes:
- Post-transplantation lymphoma
- Burkitt's lymphoma
- Hodgkin's lymphoma
- T-/NK-cell lymphoma
- Unresponsive to, or relapsed after, at least 1 prior chemotherapy regimen
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- Bidimensionally measurable disease by CT scan
- At least 1 lesion ≥ 1.5 cm in the greatest diameter
- Age 18 and over
- ECOG 0-2 OR
- Karnofsky 50-100%
- Life expectancy More than 3 months
- Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3 (no growth factor support within the past 4 weeks)
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 50,000/mm^3 (no platelet transfusions within the past 4 weeks)
- Hepatic
- Bilirubin ≤ 2.0 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN (5 times ULN in patients with liver involvement)
- No active hepatitis B or C
- Renal
- Creatinine clearance ≥ 60 mL/min
- Sodium > 130 mmol/L
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- At least 4 weeks since prior immunotherapy
- At least 4 weeks since prior chemotherapy
- At least 4 weeks since prior radiotherapy
- More than 4 weeks since prior major surgery unless fully recovered
- Recovered from all prior therapy
- At least 4 weeks since prior investigational agents
Who cannot join
- primary or secondary CNS lymphoma or HIV-related lymphoma
- known brain metastases
- myocardial infarction within the past 6 months
- acute ischemia or new conduction system abnormalities by electrocardiogram
- symptomatic congestive heart failure
- unstable angina pectoris
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- cardiac arrhythmia
- hospitalized
- pregnant or nursing
- other uncontrolled illness
- ongoing or active systemic infection
- psychiatric illness or social situation that would preclude study compliance
- history of allergic reaction attributable to compounds of similar chemical or biological composition to study drugs
- sensitivity to boron, mannitol, bortezomib, or ganciclovir
- concurrent corticosteroids (≥ 10 mg of prednisone or equivalent)
- concurrent radiotherapy
- other concurrent anticancer therapy
- other concurrent investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: EBV as Therapeutic Target: A Pilot Study of Inducing and Targeting EBV-TK in EBV-Positive Lymphomas by Combination of Bortezomib and Ganciclovir
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Epstein Barr virus can cause cancer and lymphoproliferative disorders. Ganciclovir is an antiviral drug that acts against the Epstein Barr virus. Giving ganciclovir together with bortezomib may kill more Epstein Barr virus-infected cancer cells.
PURPOSE: This clinical trial is studying how well giving bortezomib together with ganciclovir works in treating patients with relapsed or refractory Epstein Barr virus-positive lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Maximum Tolerated Dose (MTD) of bortezomib in patients with relapsed or refractory Epstein Barr virus-positive lymphoma.
Secondary
- Assess the antitumor effect of this regimen in these patients.
OUTLINE: This is a pilot, open-label, dose-escalation study of bortezomib.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11. Patients also receive ganciclovir IV twice daily on days 1-14. Treatment repeats every 21 days for a maximum of 3 courses.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for this study.
- Conditions
- Lymphoma, Lymphoproliferative Disorder
- Being tested
- bortezomib + ganciclovir
- Keywords
- recurrent adult Hodgkin lymphoma, recurrent adult Burkitt lymphoma, post-transplant lymphoproliferative disorder, recurrent adult grade III lymphomatoid granulomatosis, angioimmunoblastic T-cell lymphoma, adult grade III lymphomatoid granulomatosis
- Medical subject headings
- Lymphoma, Lymphoproliferative Disorders, Hodgkin Disease, Burkitt Lymphoma, Immunoblastic Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomib + ganciclovirDrug
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11. Patients also receive ganciclovir IV twice daily on days 1-14. Treatment repeats every 21 days for a maximum of 3 courses.
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib + ganciclovir | Experimental | Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11. Patients also receive ganciclovir IV twice daily on days 1-14. Treatment repeats every 21 days for a maximum of 3 courses. Receives: Drug: bortezomib + ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of Bortezomib in patients with relapsed or refractory EBV + lymphomas
Measured: 3 weeks
Secondary outcomes (1)
Bortezomib in inducing lytic gene expression in EBV-infected lymphoma cells
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2004 (estimated)
- Study startMar 2005
- Primary completionJul 2010
Why it stopped: study could not recruit any more patients
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.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven De Vos, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093704
- Sponsor's protocol ID
- CDR0000389476
- Other IDs
- UCLA-0403021-01, MILLENNIUM-VEL-04-108, MILLENNIUM-EBV-NHL-01
- Status last verified
- Aug 2012
- First submitted
- 6 Oct 2004
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EBV as Therapeutic Target: A Pilot Study of Inducing and Targeting EBV-TK in EBV-Positive Lymphomas by Combination of Bortezomib and Ganciclovir
- ClinicalTrials.gov ID
- NCT00093704
- Acronym / sponsor ID
- CDR0000389476
- Conditions
- Lymphoma, Lymphoproliferative Disorder
- Keywords
- recurrent adult Hodgkin lymphoma, recurrent adult Burkitt lymphoma, post-transplant lymphoproliferative disorder, recurrent adult grade III lymphomatoid granulomatosis, angioimmunoblastic T-cell lymphoma, adult grade III lymphomatoid granulomatosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study could not recruit any more patients
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Jul 2010 (actual)
- First posted
- 8 Oct 2004 (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: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Epstein Barr virus can cause cancer and lymphoproliferative disorders. Ganciclovir is an antiviral drug that acts against the Epstein Barr virus. Giving ganciclovir together with bortezomib may kill more Epstein Barr virus-infected cancer cells.
PURPOSE: This clinical trial is studying how well giving bortezomib together with ganciclovir works in treating patients with relapsed or refractory Epstein Barr virus-positive lymphoma.
Detailed description
OBJECTIVES:
Primary
- Maximum Tolerated Dose (MTD) of bortezomib in patients with relapsed or refractory Epstein Barr virus-positive lymphoma.
Secondary
- Assess the antitumor effect of this regimen in these patients.
OUTLINE: This is a pilot, open-label, dose-escalation study of bortezomib.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11. Patients also receive ganciclovir IV twice daily on days 1-14. Treatment repeats every 21 days for a maximum of 3 courses.
Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bortezomib + ganciclovir | Experimental | Drug: bortezomib + ganciclovirPatients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11. Patients also receive ganciclovir IV twice daily on days 1-14. Treatment repeats every 21 days for a maximum of 3 courses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Histologically confirmed Epstein Barr virus-positive lymphoma, including the following subtypes:
- Unresponsive to, or relapsed after, at least 1 prior chemotherapy regimen
- Bidimensionally measurable disease by CT scan
- At least 1 lesion ≥ 1.5 cm in the greatest diameter
- Age 18 and over
Key exclusion criteria (18 listed)
- primary or secondary CNS lymphoma or HIV-related lymphoma
- known brain metastases
- myocardial infarction within the past 6 months
- acute ischemia or new conduction system abnormalities by electrocardiogram
- symptomatic congestive heart failure
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 + ganciclovirPatients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11. Patients also receive ganciclovir IV twice daily on days 1-14. Treatment repeats every 21 days for a maximum of 3 courses. | Drug | Bortezomib + ganciclovir |
Primary outcome
MTD of Bortezomib in patients with relapsed or refractory EBV + lymphomas
Time frame: 3 weeks
1 secondary outcome
Bortezomib in inducing lytic gene expression in EBV-infected lymphoma cells
Time frame: 3 weeks
Results and safety
The study was stopped early (reason given: study could not recruit any more patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
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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.
Sven De Vos, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bortezomib + ganciclovir in people with Lymphoma and Lymphoproliferative Disorder, run by Jonsson Comprehensive Cancer Center 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 32 inclusion and 18 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 31 Jul 2020. 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 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.
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: study could not recruit any more patients). 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?
MTD of Bortezomib in patients with relapsed or refractory EBV + lymphomas (time frame: 3 weeks). 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 31 Jul 2020.