|
Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus Clinical research trials and Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus. Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus clinical trial. Human subjects often get the best healthcare possible for their Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "G" Clinical Trials Conditions > Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus  Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus
Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus
For Condition: Lymphoma,childhood Hodgkin's lymphoma,childhood non-Hodgkin's lymphoma,angiocentric immunoproliferative lesions,Leukemia,small intestine cancer
Status: Recruiting
Sponsor(s): Boston Medical Center ,
Synopsis: 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.
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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DouglasFaller, Study Chair, Boston Medical Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Steven Horwitz 212-639-8889
Methodist Cancer Center at Methodist Hospital *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Michael Niemeier 317-929-5820
Istituto Nazionale per lo Studio e la Cura dei Tumori *Recruiting*
Milan, , 20133
Italy
Recruiting Alessandro Gianni 39-02-239-0761
Medizinische Hochschule Hannover *Recruiting*
Hannover, , D-30625
Germany
Recruiting Christoph Klein 49-511-532-6710
Cancer Research Center at Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting Douglas Faller 617-638-8000
Hopital Necker *Recruiting*
Paris, , 75743
France
Recruiting Olivier Hermine 33-1-44-381-742
Additional Information:
Study ID Numbers: CDR0000064947; NCI-V00-1609,BUMC-3756,BUSM-FDR001532
Study Start Date:
Record last reviewed: February 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006340
Other Lymphoma Studies:
1. Siplizumab in Treating Patients With Lymphoproliferative Disorder
2. Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus
3. 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
Related Studies:
Other Lymphoma Clinical Trials
Other Clinical Trials
Other Paris Clinical Trials
Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated with the Epstein Barr Virus
|
|
|
|
|
|
|
|
