A PHASE I TRIAL OF BUTYRATE AND GANCICLOVIR IN EBV-ASSOCIATED MALIGNANCIES
Phase 1
3 Years
N/A
3 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma, Precancerous Condition, Small Intestine Cancer
Both
Leukemia, Lymphoma, Precancerous Condition, Small Intestine Cancer
Trial Information
A PHASE I TRIAL OF BUTYRATE AND GANCICLOVIR IN EBV-ASSOCIATED MALIGNANCIES
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.
Inclusion 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
- No concurrent cytotoxic chemotherapy
Endocrine therapy:
- No concurrent steroids
Radiotherapy:
- Recovered from prior radiotherapy
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Douglas V. Faller, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Boston Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000064947
NCT ID:
NCT00006340
Start Date:
December 1994
Completion Date:
Related Keywords:
- Leukemia
- Lymphoma
- Precancerous Condition
- Small Intestine Cancer
- 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
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- stage I grade 3 follicular lymphoma
- stage I adult diffuse small cleaved cell lymphoma
- stage I adult diffuse mixed cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult immunoblastic large cell lymphoma
- stage I adult lymphoblastic lymphoma
- stage I adult Burkitt lymphoma
- T-cell large granular lymphocyte leukemia
- stage II grade 1 follicular lymphoma
- stage II grade 2 follicular lymphoma
- stage II grade 3 follicular lymphoma
- stage II adult diffuse small cleaved cell lymphoma
- stage II adult diffuse mixed cell lymphoma
- stage II adult diffuse large cell lymphoma
- stage II adult immunoblastic large cell lymphoma
- stage II adult lymphoblastic lymphoma
- stage II adult Burkitt lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- AIDS-related peripheral/systemic lymphoma
- AIDS-related primary CNS lymphoma
- stage I childhood small noncleaved cell lymphoma
- stage I childhood large cell lymphoma
- stage II childhood small noncleaved cell lymphoma
- stage II childhood large cell lymphoma
- stage III childhood small noncleaved cell lymphoma
- stage III childhood large cell lymphoma
- stage IV childhood small noncleaved cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- stage I mantle cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage II mantle cell lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage II small lymphocytic lymphoma
- stage II marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoproliferative Disorders
- Precancerous Conditions
- Lymphoma, Large-Cell, Immunoblastic
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Intestinal Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Methodist Cancer Center at Methodist Hospital | Indianapolis, Indiana 46202 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
