Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003435
Status:
WITHDRAWN
Last Update Posted:
2013-03-07
First Post:
1999-11-01
Brief Title:
Antiviral Therapy Plus Either Peripheral Stem Cell or Umbilical Cord Blood Transplantation in Treating Patients Who Are HIV Positive and Have Hematologic Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Pilot Study Involving Administration of Combination Anti-Retroviral Therapy and Transplantation of HLA-Matched Sibling Peripheral Blood Stem Cells or Partially HLA-Matched Unrelated Umbilical Cord Blood In Adults With HIV Infection and Hematologic Malignancies
Status:
WITHDRAWN
Status Verified Date:
2000-12
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 agents are drugs that act against viruses and may be an effective treatment for HIV Peripheral stem cell transplantation or umbilical cord blood transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells Combining either umbilical cord blood transplantation or peripheral stem cell transplantation with antiviral therapy may be an effective treatment for HIV-positive patients who have hematologic cancer
PURPOSE Phase I trial to study the effectiveness of antiviral therapy plus either peripheral stem cell transplantation or umbilical cord blood transplantation in treating HIV-positive patients who have refractory or recurrent hematologic cancer
PURPOSE Phase I trial to study the effectiveness of antiviral therapy plus either peripheral stem cell transplantation or umbilical cord blood transplantation in treating HIV-positive patients who have refractory or recurrent hematologic cancer
Detailed Description:
OBJECTIVES I Determine the feasibility and safety of combination antiretroviral therapy followed by HLA matched sibling peripheral blood stem cell or unrelated umbilical cord blood transplants in HIV infected adults with hematologic malignancies II Measure the effects of this treatment on HIV viral burden in the serum and tissues of these patients III Measure immune reconstitution following treatment in this patient population
OUTLINE Patients receive a combination of 3 antiretroviral agents beginning at least 3 weeks prior to the initiation of the myeloablative conditioning regimen The antiretroviral agents are discontinued on days -5 to -1 prior to transplant Beginning on day 0 the antiretroviral agents are restarted and continue indefinitely Patients who are given umbilical cord blood UCB transplants undergo collection of autologous peripheral blood stem cells PBSC prior to the myeloablative conditioning regimen in case there is UCB graft failure Prior to PBSC or UCB transplantation on day 0 all patients receive a myeloablative conditioning regimen The conditioning regimen consists of total body irradiation twice a day on days -9 to -5 and melphalan IV over 60 minutes on days -4 to -2 Patients receiving UCB transplant also receive anti-thymocyte globulin over 6 hours on days -3 to -1 Patients are followed every 3 months for 3 years then annually for the next 3 years
PROJECTED ACCRUAL A total of 6 patients will be accrued for this study over 2 years
OUTLINE Patients receive a combination of 3 antiretroviral agents beginning at least 3 weeks prior to the initiation of the myeloablative conditioning regimen The antiretroviral agents are discontinued on days -5 to -1 prior to transplant Beginning on day 0 the antiretroviral agents are restarted and continue indefinitely Patients who are given umbilical cord blood UCB transplants undergo collection of autologous peripheral blood stem cells PBSC prior to the myeloablative conditioning regimen in case there is UCB graft failure Prior to PBSC or UCB transplantation on day 0 all patients receive a myeloablative conditioning regimen The conditioning regimen consists of total body irradiation twice a day on days -9 to -5 and melphalan IV over 60 minutes on days -4 to -2 Patients receiving UCB transplant also receive anti-thymocyte globulin over 6 hours on days -3 to -1 Patients are followed every 3 months for 3 years then annually for the next 3 years
PROJECTED ACCRUAL A total of 6 patients will be accrued for this study over 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G98-1458 | None | None | None |
| DUMC-97028 | None | None | None |