Ganciclovir Plus Arginine Butyrate in Treating Patients W... | NCT00006340 | Trialant
NCT00006340
Sponsor
Boston Medical Center
Status
Completed
Last Update Posted
Jul 26, 2013Estimated
Enrollment
Not provided
Phase
Phase 1
Conditions
Leukemia
Lymphoma
Precancerous Condition
Small Intestine Cancer
Interventions
arginine butyrate
ganciclovir
Countries
United States
France
Germany
Italy
Protocol Section
Identification Module
NCT ID
NCT00006340
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000064947
Secondary IDs
ID
Type
Description
Link
BUMC-3756
BUSM-FDR001532
NCI-V00-1609
Brief Title
Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated With the Epstein Barr Virus
Official Title
A PHASE I TRIAL OF BUTYRATE AND GANCICLOVIR IN EBV-ASSOCIATED MALIGNANCIES
Acronym
Not provided
Organization
Boston Medical CenterOTHER
Status Module
Record Verification Date
Jul 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 1994
Primary Completion Date
Jul 2000Actual
Completion Date
Jul 2000Actual
First Submitted Date
Oct 4, 2000
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 25, 2013
Last Update Posted Date
Jul 26, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Boston Medical CenterOTHER
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: The Epstein Barr virus can cause cancer and lymphoproliferative disorders. Ganciclovir is an antiviral drug that acts against the Epstein Barr virus. Arginine butyrate may make virus cells more sensitive to ganciclovir. Combining ganciclovir and arginine butyrate may kill more Epstein Barr virus cells and tumor cells.
PURPOSE: Phase I trial to study the effectiveness of arginine butyrate plus ganciclovir in treating patients who have cancer or lymphoproliferative disorders that are associated with the Epstein Barr virus.
Detailed Description
OBJECTIVES:
Determine the safety, toxicity, and the reversibility of toxicity of arginine butyrate in patients with Epstein Barr virus-induced malignancies or lymphoproliferative disorders.
Determine the clinical pharmacology of arginine butyrate when administered with ganciclovir, including plasma half life and major routes of elimination in these patients.
Determine the biologic effects of arginine butyrate in terms of inducing sensitivity to ganciclovir in tissue samples from selected patients.
Determine the antitumor activity of this treatment regimen in these patients.
OUTLINE: Patients receive ganciclovir IV over 1 hour twice a day on days -1 to 21 for the first course (days 0-21 for all subsequent courses) and escalating doses of arginine butyrate IV continuously on days 0-21. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for a minimum of 42 days.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 years.
Conditions Module
Conditions
Leukemia
Lymphoma
Precancerous Condition
Small Intestine Cancer
Keywords
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
recurrent childhood lymphoblastic lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
arginine butyrate
Drug
ganciclovir
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy or lymphoproliferative disease including the following:
Nasopharyngeal carcinoma
Hodgkin's lymphoma
African Burkitt's lymphoma
T-cell non-Hodgkin's lymphoma
B-cell non-Hodgkin's lymphoma if Epstein Barr Virus (EBV) positive
Other lymphomas associated with immunodeficiency or immunosuppression, including AIDS-related lymphoma
B-cell lymphoproliferative disorders
Monoclonal or oligoclonal B-cell lymphoid disease (no polyclonal disease)
EBV positive by immunohistochemistry or in situ hybridization
Negative serology for EBV allowed
PATIENT CHARACTERISTICS:
Age:
3 and over
Performance status:
Any status
Hematopoietic:
Absolute granulocyte count at least 1,000/mm^3
Platelet count at least 50,000/mm^3
Hepatic:
Bilirubin no greater than 1.5 mg/dL
Aminotransferase less than 2 times normal
Renal:
Creatinine less than 3.0 mg/dL
Creatinine clearance greater than 30 mL/min
Cardiovascular:
No acute myocardial infarction within the past 6 months
No atrial fibrillation within the past 6 months
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Prior bone marrow or stem cell transplantation allowed
No concurrent immunotherapy
No concurrent interferon or tacrolimus
Chemotherapy:
At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
Perrine SP, Hermine O, Small T, Suarez F, O'Reilly R, Boulad F, Fingeroth J, Askin M, Levy A, Mentzer SJ, Di Nicola M, Gianni AM, Klein C, Horwitz S, Faller DV. A phase 1/2 trial of arginine butyrate and ganciclovir in patients with Epstein-Barr virus-associated lymphoid malignancies. Blood. 2007 Mar 15;109(6):2571-8. doi: 10.1182/blood-2006-01-024703. Epub 2006 Nov 21.