EBV LymphomasPhase 2NCT00917826
Study of Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+) Lymphoid Malignancies
A Phase 2 study testing Arginine Butyrate, Ganciclovir and Valganciclovir in people with EBV Lymphomas and Lympho-proliferative Diseases, run by HemaQuest Pharmaceuticals Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess whether administration of Arginine Butyrate + ganciclovir/valganciclovir for up to three 21-day cycles is tolerable, and results in partial or complete responses in patients with EBV(+) lymphoid malignancies. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- EBV Lymphomas, Lympho-proliferative Diseases
- What is being tested?
- Arginine Butyrate, Ganciclovir and Valganciclovir
- 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
- Sep 2008to Sep 2009
- Phase
- Phase 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 3 years. (No dosing or adverse event data are currently available on the use of valganciclovir in patients < 16 years of age.)
- Life expectancy of > 3 months.
- ECOG Performance Status 0-2 or Karnofsky Performance Scale ≥ 60%.
- Baseline (untransfused) HbF level > 2%
- Normal organ and marrow function defined as: (i) absolute neutrophil count of ≥ 1,000/µL. (ii) platelets ≥ 50,000/ µL. (iii) total bilirubin of ≤ 2.0 x upper limit of normal. (iv) AST (SGOT)/ALT(SGPT) of ≤ 2.0 x institutional upper limit of normal. (v) creatinine within normal range for institution.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
- Able and willing to give informed consent.
Who cannot join
- Patients that have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entry, or those who have not recovered form adverse events due to agents administered 4 weeks earlier.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Arginine Butyrate, ganciclovir or valganciclovir.
- Patients who have an acute myocardial infarction or onset of atrial fibrillation within the past 6 months.
- Uncontrolled intercurrent illness including, but not limited to , ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Tumor impinging on an organ or anatomical structure deemed critical by the investigator.
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical Center
Hackensack, New Jersey, 07601
About this study
Official title: A Phase II Trial of Low-Dose Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+)Lymphoid Malignancies
The purpose of this study is to assess whether administration of Arginine Butyrate + ganciclovir/valganciclovir for up to three 21-day cycles is tolerable, and results in partial or complete responses in patients with EBV(+) lymphoid malignancies.
- Conditions
- EBV Lymphomas, Lympho-proliferative Diseases
- Being tested
- Arginine Butyrate, Ganciclovir, Valganciclovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginine ButyrateDrug
Also called HQK-1004
1,000 mg/kg/day administered IV over 24 hours/day for 5 days (Days 1-5 of each 21 day cycle)
GanciclovirDrug
5 mg/kg administered IV over 1 hour (Days 1-5 of each 21 day cycle)
ValganciclovirDrug
900 mg BID for 16 days (Days 6-21 of each 21 day cycle)
| Study group | Role | What they receive |
|---|---|---|
| Arginine Butyrate + Ganciclovir/Valganciclovir | Experimental | Not described Receives: Drug: Arginine Butyrate; Drug: Ganciclovir; Drug: Valganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
Measured: Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)
Secondary outcomes (2)
Progression Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
Measured: Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)
Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam
Measured: Up to three 21-day cycles. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessments may continue after treatment is discontinued.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV LymphomasStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemaQuest Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston University
- Investigators
- Adam Lerner, M.D., Principal investigator, Boston University School of Mediciine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917826
- Sponsor's protocol ID
- P2 L-D AB
- Status last verified
- Jul 2011
- First submitted
- 8 Jun 2009
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Low-Dose Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+)Lymphoid Malignancies
- ClinicalTrials.gov ID
- NCT00917826
- Acronym / sponsor ID
- P2 L-D AB
- Conditions
- EBV Lymphomas, Lympho-proliferative Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- HemaQuest Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boston University
- Study start
- Sep 2008
- Primary completion
- Sep 2009 (actual)
- First posted
- 10 Jun 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.
The purpose of this study is to assess whether administration of Arginine Butyrate + ganciclovir/valganciclovir for up to three 21-day cycles is tolerable, and results in partial or complete responses in patients with EBV(+) lymphoid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arginine Butyrate + Ganciclovir/Valganciclovir | Experimental | Drug: Arginine Butyrate, Drug: Ganciclovir, Drug: Valganciclovir |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 3 years. (No dosing or adverse event data are currently available on the use of valganciclovir in patients < 16 years of age.)
- Life expectancy of > 3 months.
- ECOG Performance Status 0-2 or Karnofsky Performance Scale ≥ 60%.
- Baseline (untransfused) HbF level > 2%
- Normal organ and marrow function defined as: (i) absolute neutrophil count of ≥ 1,000/µL. (ii) platelets ≥ 50,000/ µL. (iii) total bilirubin of ≤ 2.0 x upper limit of normal. (iv) AST (SGOT)/ALT(SGPT) of ≤ 2.0 x institutional upper limit of normal. (v) creatinine within normal range for institution.
Key exclusion criteria (7 listed)
- Patients that have received chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entry, or those who have not recovered form adverse events due to agents administered 4 weeks earlier.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Arginine Butyrate, ganciclovir or valganciclovir.
- Patients who have an acute myocardial infarction or onset of atrial fibrillation within the past 6 months.
- Uncontrolled intercurrent illness including, but not limited to , ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| Arginine ButyrateAlso: HQK-10041,000 mg/kg/day administered IV over 24 hours/day for 5 days (Days 1-5 of each 21 day cycle) | Drug | Arginine Butyrate + Ganciclovir/Valganciclovir |
| Ganciclovir5 mg/kg administered IV over 1 hour (Days 1-5 of each 21 day cycle) | Drug | Arginine Butyrate + Ganciclovir/Valganciclovir |
| Valganciclovir900 mg BID for 16 days (Days 6-21 of each 21 day cycle) | Drug | Arginine Butyrate + Ganciclovir/Valganciclovir |
Primary outcome
Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
Time frame: Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)
2 secondary outcomes
Progression Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
Time frame: Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)
Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam
Time frame: Up to three 21-day cycles. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessments may continue after treatment is discontinued.)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2011.
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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.
Adam Lerner, M.D. principal investigator
Boston University School of Mediciine
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 Arginine Butyrate, Ganciclovir and Valganciclovir in people with EBV Lymphomas and Lympho-proliferative Diseases, run by HemaQuest Pharmaceuticals Inc. 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 7 inclusion and 7 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 1 Aug 2011. 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?
The study was stopped early. 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?
Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007) (time frame: Every three weeks. If a response is recorded evaluation continues until an objective determination of disease progression is made (assessment may continue after treatment is discontinued.)). 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 1 Aug 2011.