Expired Study
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Durham, North Carolina 27710


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma, acute myelogenous leukemia, or acute lymphocytic leukemia that is refractory to or relapsed after prior therapy Must be HIV seropositive confirmed by Western blot Must have a 6/6 HLA matched sibling donor or 6/6, 5/6, or 4/6 HLA matched umbilical cord blood (UCB) from the New York Blood Center's Unrelated UCB Bank that is not homozygous for the CCR-5 mutation No active primary CNS lymphoma or chronic CNS infection No history of AIDS defining opportunistic infection or active invasive aspergillus infection A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: 18 to 55 Performance status: Karnofsky 70-100% Life expectancy: At least 6 months (unless due to hematologic malignancy) Hematopoietic: Peripheral CD4 count greater than 100/mm3 Hepatic: Transaminases no greater than 4 times normal Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months Normal cardiac function (LVEF greater than 40%) Pulmonary: FVC and FEV1 greater than 70% of predicted DLCO at least 60% of predicted Other: No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix within the past 5 years Not pregnant (must have negative pregnancy test within 2 weeks of therapy) PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow, peripheral blood stem cell, or umbilical cord blood transplant Chemotherapy: Cumulative lifetime dose of doxorubicin no greater than 450 mg/m2 (or equivalent dose of mitoxantrone or daunorubicin) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent involvement in any other clinical trial that may affect hematologic engraftment


Study is Available At:


Original ID:

CDR0000066461


NCT ID:

NCT00003435


Secondary ID:

DUMC-97028


Study Acronym:


Brief Title:

Antiviral Therapy Plus Either Peripheral Stem Cell or Umbilical Cord Blood Transplantation in Treating Patients Who Are HIV Positive and Have Hematolo


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 Malig


Overall Status:

Withdrawn


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clayton Smith, MD
Study Chair
Duke Cancer Institute

Study Dates

Start Date:May 1998
Verification Date:December 2000
Last Changed Date:March 6, 2013
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:anti-thymocyte globulin
Intervention Type:Drug
Name:melphalan
Intervention Type:Procedure
Name:antiviral therapy
Intervention Type:Procedure
Name:bone marrow ablation with stem cell support
Intervention Type:Procedure
Name:peripheral blood stem cell transplantation
Intervention Type:Procedure
Name:umbilical cord blood transplantation
Intervention Type:Radiation
Name:radiation therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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