Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein
Barr Virus
This study is currently recruiting patients.
Sponsored by: |
Boston Medical Center |
Information provided by: |
National Cancer Institute (NCI) |
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
|
Treatment or Intervention |
Phase |
Cancer grade I lymphomatoid granulomatosis grade II lymphomatoid granulomatosis recurrent grade I lymphomatoid granulomatosis recurrent grade II lymphomatoid granulomatosis
|
Drug: arginine butyrate Drug: ganciclovir Procedure: antiviral therapy Procedure: drug modulation
|
Phase I
|
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Arginine Butyrate and Ganciclovir in Patients With Epstein Barr Virus-Induced Malignancies or Lymphoproliferative
Disorders
Further Study Details:
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 above,
Genders Eligible for Study:
Both
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:
Performance 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:
Radiotherapy:
- Recovered from prior radiotherapy
Surgery:
Location
and Contact
Information
Indiana Methodist Cancer Center at Methodist Hospital, Indianapolis,
Indiana,
46202,
United States; Recruiting
Michael Ray Niemeier, MD
317-929-5820
Massachusetts Cancer Research Center at Boston Medical Center, Boston,
Massachusetts,
02118,
United States; Recruiting
Douglas V. Faller, MD, PhD
617-638-4173
New York Memorial Sloan-Kettering Cancer Center, New York,
New York,
10021,
United States; Recruiting
Steven M. Horwitz, MD
212-639-8889
France Hopital Necker, Paris,
75743,
France; Recruiting
Olivier Hermine
33-1-44-381-742
Germany Medizinische Hochschule Hannover, Hannover,
D-30625,
Germany; Recruiting
Christoph Klein, MD, PhD
49-511-532-6710
Italy Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan,
20133,
Italy; Recruiting
Alessandro M. Gianni, MD
39-02-239-0761
Study chairs or principal investigators
Douglas V. Faller, MD, PhD, Study Chair, Boston Medical Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
Faller DV, Mentzer SJ, Perrine SP. Induction of the Epstein-Barr virus thymidine kinase gene with concomitant nucleoside
antivirals as a therapeutic strategy for Epstein-Barr virus-associated malignancies. Curr Opin Oncol. 2001 Sep;13(5):360-7.
Review.
Mentzer SJ, Perrine SP, Faller DV. Epstein--Barr virus post-transplant lymphoproliferative disease and virus-specific therapy:
pharmacological re-activation of viral target genes with arginine butyrate. Transpl Infect Dis. 2001 Sep;3(3):177-85. Review.
Mentzer SJ, Fingeroth J, Reilly JJ, Perrine SP, Faller DV. Arginine butyrate-induced susceptibility to ganciclovir in an
Epstein-Barr-virus-associated lymphoma. Blood Cells Mol Dis. 1998 Jun;24(2):114-23.
Study ID Numbers:
CDR0000064947; BUMC-3756; BUSM-FDR001532; NCI-V00-1609
Record last reviewed:
February 2001
Record first received:
October 4, 2000
ClinicalTrials.gov Identifier:
NCT00006340Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-17