Status:
TERMINATED
Study of Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+) Lymphoid Malignancies
Lead Sponsor:
HemaQuest Pharmaceuticals Inc.
Collaborating Sponsors:
Boston University
Conditions:
EBV Lymphomas
Lympho-proliferative Diseases
Eligibility:
All Genders
3+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00917826
Start Date
September 1 2008
Last Update
August 1 2011
Active Locations (1)
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1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601