Overview

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

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Antilymphocyte Serum
Antiviral Agents
Melphalan
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