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A PHASE I TRIAL OF BUTYRATE AND GANCICLOVIR IN EBV-ASSOCIATED MALIGNANCIES


Phase 1
3 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma, Precancerous Condition, Small Intestine Cancer

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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 CenterNew York, New York  10021
Methodist Cancer Center at Methodist HospitalIndianapolis, Indiana  46202
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118