Antiviral Therapy Plus Either Peripheral Stem Cell or Umbilical Cord Blood Transplantation in Treating Patients Who Are HIV Positive and Have Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00003435|
Recruitment Status : Withdrawn
First Posted : June 9, 2004
Last Update Posted : March 7, 2013
|First Submitted Date ICMJE||November 1, 1999|
|First Posted Date ICMJE||June 9, 2004|
|Last Update Posted Date||March 7, 2013|
|Study Start Date ICMJE||May 1998|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003435 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Antiviral Therapy Plus Either Peripheral Stem Cell or Umbilical Cord Blood Transplantation in Treating Patients Who Are HIV Positive and Have Hematologic Cancer|
|Official Title ICMJE||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|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Study Arms ICMJE||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Actual Enrollment ICMJE
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages ICMJE||18 Years to 55 Years (Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00003435|
|Other Study ID Numbers ICMJE||CDR0000066461
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Duke University|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|PRS Account||Duke University|
|Verification Date||December 2000|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP