Clinical trial NCT00917826: Study of Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+) Lymphoid Malignancies
Official title: A Phase II Trial of Low-Dose Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+)Lymphoid Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: EBV Lymphomas
Lympho-proliferative Diseases
Lead sponsor: HemaQuest Pharmaceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: Boston University
First posted: 2009-06-10
Enrollment: 1
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Response Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
timeFrame: 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:
measure: Progression Rate (using Revised Response Criteria for Malignant Lymphoma, Cheson et al., JCO 2007)
timeFrame: 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.)
measure: Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam
timeFrame: 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.)
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
Study officials:
affiliation: Boston University School of Mediciine
name: Adam Lerner, M.D.
role: PRINCIPAL_INVESTIGATOR
References: