Ignite Creation Date:
2024-05-05 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006340
Status:
COMPLETED
Last Update Posted:
2013-07-26
First Post:
2000-10-04
Brief Title:
Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated With the Epstein Barr Virus
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
A PHASE I TRIAL OF BUTYRATE AND GANCICLOVIR IN EBV-ASSOCIATED MALIGNANCIES
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V00-1609 | None | None | None |
| BUMC-3756 | None | None | None |
| BUSM-FDR001532 | None | None | None |