Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006264
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2000-09-11
Brief Title:
Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma
Sponsor:
AIDS Malignancy Consortium
Organization:
AIDS Malignancy Consortium
Study Overview
Official Title:
A Phase II Trial Of Induction Therapy With Zidovudine Interleukin-2 And Ganciclovir In The Treatment Of HIV Positive Primary Central Nervous System Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-02
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 Antiviral drugs such as zidovudine and ganciclovir act against viruses and may be an effective treatment for HIV Interleukin-2 may stimulate a persons white blood cells to kill lymphoma cells Combining these treatments may be effective in treating AIDS-related primary central nervous system lymphoma
PURPOSE Phase II trial to study the effectiveness of combining zidovudine ganciclovir and interleukin-2 in treating patients who have AIDS-related primary central nervous system lymphoma
PURPOSE Phase II trial to study the effectiveness of combining zidovudine ganciclovir and interleukin-2 in treating patients who have AIDS-related primary central nervous system lymphoma
Detailed Description:
OBJECTIVES
Determine the safety and toxicity of zidovudine interleukin-2 and ganciclovir in patients with AIDS related primary central nervous system lymphoma
Determine the response rate and overall survival of these patients treated with this regimen
OUTLINE This is a multicenter study
Induction therapy Patients receive zidovudine AZT IV and ganciclovir IV over 1 hour every 12 hours on days 1-14 Patients also receive interleukin-2 IL-2 IV every 12 hours on days 1-14 and a combination antiretroviral therapy consisting of nucleoside reverse transcriptase inhibitors one of which must be AZT nonnucleoside reverse transcriptase inhibitors and protease inhibitors AZT and ganciclovir treatment continues for an additional 7 days if partial response is achieved
Maintenance therapy Patients receive IL-2 subcutaneously 3 times a week for 6 months Patients also receive oral ganciclovir 3 times a day and combination antiretroviral therapy AZT allowed but not required Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 10-30 patients will be accrued for this study
Determine the safety and toxicity of zidovudine interleukin-2 and ganciclovir in patients with AIDS related primary central nervous system lymphoma
Determine the response rate and overall survival of these patients treated with this regimen
OUTLINE This is a multicenter study
Induction therapy Patients receive zidovudine AZT IV and ganciclovir IV over 1 hour every 12 hours on days 1-14 Patients also receive interleukin-2 IL-2 IV every 12 hours on days 1-14 and a combination antiretroviral therapy consisting of nucleoside reverse transcriptase inhibitors one of which must be AZT nonnucleoside reverse transcriptase inhibitors and protease inhibitors AZT and ganciclovir treatment continues for an additional 7 days if partial response is achieved
Maintenance therapy Patients receive IL-2 subcutaneously 3 times a week for 6 months Patients also receive oral ganciclovir 3 times a day and combination antiretroviral therapy AZT allowed but not required Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 10-30 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000068204 | OTHER | NCI | None |