Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated With the Epstein Barr Virus
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Precancerous Condition Small Intestine Cancer |
Drug: arginine butyrate Drug: ganciclovir |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A PHASE I TRIAL OF BUTYRATE AND GANCICLOVIR IN EBV-ASSOCIATED MALIGNANCIES |
| Study Start Date: | December 1994 |
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.
Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- No concurrent cytotoxic chemotherapy
Endocrine therapy:
- No concurrent steroids
Radiotherapy:
- Recovered from prior radiotherapy
Surgery:
- Not specified
Contacts and Locations| United States, Indiana | |
| Methodist Cancer Center at Methodist Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Cancer Research Center at Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| France | |
| Hopital Necker | |
| Paris, France, 75743 | |
| Germany | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, D-30625 | |
| Italy | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | |
| Milan, Italy, 20133 | |
| Study Chair: | Douglas V. Faller, MD, PhD | Boston Medical Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00006340 History of Changes |
| Other Study ID Numbers: | CDR0000064947, BUMC-3756, BUSM-FDR001532, NCI-V00-1609 |
| Study First Received: | October 4, 2000 |
| Last Updated: | January 27, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
small intestine lymphoma childhood immunoblastic large cell lymphoma grade I lymphomatoid granulomatosis grade II lymphomatoid granulomatosis adult grade III lymphomatoid granulomatosis recurrent adult grade III lymphomatoid granulomatosis childhood grade III lymphomatoid granulomatosis recurrent childhood grade III lymphomatoid granulomatosis recurrent grade I lymphomatoid granulomatosis recurrent grade II lymphomatoid granulomatosis stage II childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Precancerous Conditions Lymphoma, Large-Cell, Immunoblastic Duodenal Neoplasms Ileal Neoplasms Jejunal Neoplasms Intestinal Neoplasms Neoplasms by Histologic Type Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Duodenal Diseases Intestinal Diseases Ileal Diseases Jejunal Diseases Ganciclovir Arginine butyrate Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013