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• Status: Withdrawn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