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Clinical Trial Detail

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

Complete title: A Clinical Trial of Gene-Modified Stem Cells to Generate HIV-Resistant Cells in Conjunction with Standard Chemotherapy for Treatment of Lymphoma in Patients with HIV Infection

Research Study Number 2673.00
 
Principal Investigator Mazyar Shadman
 
Phase I

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years to 66 Years (Adult, Senior)

Sexes Eligible for Study: All

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

Other exclusion criteria may apply.

Research Study Number 2673.00
 
Contact Seattle Cancer Care Alliance Intake Office
 
Telephone 800-804-8824 / 206-606-1024
 

Keywords: Hematologic Malignancies; Lymphoma, Hodgkin; Lymphoma; Lymphoproliferative Disorders; Lymphoma, Non-Hodgkin (NHL); Neoplasms; Immunoproliferative Disorders; HIV / AIDS; Virus Diseases; Immune System Diseases; Infection; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Sexually Transmitted Diseases; HIV Infections

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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