Study of Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+) Lymphoid Malignancies

HemaQuest Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

EBV Lymphomas

Lympho-proliferative Diseases

Treatments

Drug: Ganciclovir

Drug: Valganciclovir

Drug: Arginine Butyrate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00917826

P2 L-D AB

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

3+ years old

Volunteers

No Healthy Volunteers

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.