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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


Phase 1
18 Years
55 Years
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Clayton Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000066461

NCT ID:

NCT00003435

Start Date:

May 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • recurrent adult acute lymphoblastic leukemia
  • secondary acute myeloid leukemia
  • AIDS-related peripheral/systemic lymphoma
  • HIV-associated Hodgkin lymphoma
  • Leukemia
  • Lymphoma

Name

Location
Duke Comprehensive Cancer Center Durham, North Carolina  27710