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| Sponsor: | Boston Medical Center |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006340 |
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/Nonmalignant Condition Small Intestine Cancer |
Drug: arginine butyrate Drug: ganciclovir |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A PHASE I TRIAL OF BUTYRATE AND GANCICLOVIR IN EBV-ASSOCIATED MALIGNANCIES |
| Study Start Date: | December 1994 |
OBJECTIVES:
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:
EBV positive by immunohistochemistry or in situ hybridization
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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
| Study ID Numbers: | CDR0000064947, BUMC-3756, BUSM-FDR001532, NCI-V00-1609 |
| Study First Received: | October 4, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006340 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
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Anti-Infective Agents Precancerous Conditions Antineoplastic Agents Gastrointestinal Diseases Ileal Diseases Duodenal Neoplasms Leukemia Neoplasms by Site Ileal Neoplasms Jejunal Diseases Therapeutic Uses Lymphoma, Large-Cell, Immunoblastic Lymphoma Duodenal Diseases Jejunal Neoplasms |
Neoplasms by Histologic Type Immunoproliferative Disorders Digestive System Neoplasms Immune System Diseases Ganciclovir Intestinal Diseases Antiviral Agents Pharmacologic Actions Intestinal Neoplasms Lymphatic Diseases Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Arginine butyrate Lymphoproliferative Disorders |