Overview

HIV-Resistant Gene Modified Stem Cells and Chemotherapy in Treating Patients With Lymphoma With HIV Infection

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
This pilot phase I trial studies the side effects and best dose of human immunodeficiency virus (HIV)-resistant gene modified stem cells in treating HIV-positive patients who are undergoing first-line treatment for Hodgkin or Non-Hodgkin Lymphoma. Stem cells are collected from the patient and HIV-resistance genes are placed into the stem cells. The stem cells are then re-infused into the patient. These genetically modified stem cells may help the body make cells that are resistant to HIV infection.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fred Hutchinson Cancer Research Center
Collaborators:
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Carmustine
JM 3100
Lenograstim
O(6)-benzylguanine
Plerixafor
Sargramostim
Criteria
Inclusion Criteria:

- HIV-1 seropositive

- Stable, continuous antiretroviral treatment, defined as a multi-drug regimen
(excluding zidovudine, also known as azidothymidine [AZT], Retrovir) prior to
enrollment, as demonstrated by HIV plasma viral load < 50 copies/mL

- Previously untreated non-Hodgkin lymphoma or Hodgkin lymphoma; all stages of disease
are allowed; also eligible are patients who have started or completed one or more
cycles of treatment as part of a planned first line regimen, or those who have
received local radiation or surgery or corticosteroids for disease control

- Planned treatment with standard first line therapy for non-Hodgkin lymphoma (NHL) or
Hodgkin lymphoma (HL)

- Karnofsky performance score >= 70%

- Subjects must agree to use effective means to prevent conception from enrollment
through completion of the study

- Female subjects: if of child bearing potential, must have negative serum or urine
pregnancy test within 7 days of enrollment

- Subjects must be on a prophylactic regimen for Pneumocystis jiroveci pneumonia, or
agree to begin such treatment, if CD4+ cell counts are observed to be =< 200/ul in
peripheral blood

- Able to understand, and the willingness to give, informed consent for the study

Exclusion Criteria:

- Central nervous system (CNS) lymphoma: CNS involvement by lymphoma, including
parenchymal brain or spinal cord lymphoma or known presence of leptomeningeal disease
prior to registration

- Patients with renal, hepatic, pulmonary, or cardiac disease that exclude delivery of
standard chemotherapy

- Active (uncontrolled) infection requiring systemic antibiotic therapy with
antibacterial, antifungal, or antiviral agents (excluding HIV)

- Hepatitis B surface antigen positive

- Hepatitis C virus (HCV) antibody positive and detectable HCV quantitative ribonucleic
acid (RNA), with clinical evidence of cirrhosis as determined by the principal
investigator

- Requiring active treatment for Toxoplasma gondii infection

- Malignancy other than lymphoma, unless (1) in complete remission and more than 5 years
from last treatment, or (2) cervical/anal squamous cell carcinoma in situ or (3)
superficial basal cell and squamous cell cancers of the skin

- History of HIV-associated encephalopathy; dementia of any kind; seizures in the past
12 months

- Any perceived inability to directly provide informed consent (note: consent may not be
obtained by means of a legal guardian)

- Any concurrent or past medical condition that, in the opinion of the investigator,
would exclude the subject from participation

- Patients who have received a vaccine for HIV-1 or any prior gene modified cell
product, at any time

- A medical history of noncompliance with HAART or medical therapy

- Pregnant women or nursing mothers

- Use of zidovudine as part of the HAART regimen (a drug substitution for zidovudine at
the time of study entry is allowed)

- Known hypersensitivity to any of the products used in the trial - G-CSF (Neupogen,
filgrastim), plerixafor (Mozobil), or any components of the chemotherapeutic agents or
O6BG/BCNU in vivo selection regimens