Gene Therapy in HIV-Positive Patients With Non-Hodgkin's Lymphoma

NCT00002221 | Completed Phase 2

• 1 other identifier: STUDY 2
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if it is safe and effective to use gene therapy to treat non-Hodgkin's lymphoma (NHL) in HIV-positive patients. Stem cell transplantation is a procedure used to treat NHL. Stem cells are very immature cells that develop to create all of the different types of blood cells. In this study, some of your stem cells will be treated with gene therapy, meaning the cells are treated with a virus that does not cause disease. Some cells will receive a virus that contains ribozymes, enzymes that may help fight HIV. Other cells will be treated with a virus that does not contain ribozymes to see how the virus works alone. Some cells will not be treated at all. Doctors would like to see whether giving patients stem cells with ribozymes can treat NHL and stop HIV from growing at the same time.

Conditions

Lymphoma, Non-Hodgkin; HIV Infections

Keywords

Lymphoma, Non-Hodgkin; Bone Marrow; Lymphocyte Transformation; HIV-1; Retroviridae; Lymphoma, AIDS-Related; Genetic Vectors; Transduction, Genetic; Gene Transfer Techniques

Interventions

Peripheral blood stem cells DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• You may be eligible for this study if you:
• Are 18 to 60 years old.
• Have been HIV-positive at least since you were diagnosed with non-Hodgkin's lymphoma.
• Have an HIV level less than or equal to 25,000 copies/ml and a CD4 count of at least 100 cells/mm3.
• Are currently about to undergo bone marrow transplantation.
• Have responded well to cancer treatments, including chemotherapy and previous bone marrow transplantation.
• Agree to use effective barrier methods of birth control, such as condoms, during the study.
• Are on anti-HIV therapy (HAART).

You may not qualify if:

• You will not be eligible for this study if you:
• Have lymphoma affecting your nervous system.
• Have had any AIDS-related opportunistic infections in the past year.
• Have heart disease.
• Are pregnant or breast-feeding.
• Have severe diarrhea.
• Have a history of cytomegalovirus (CMV) retinitis.
• Have dementia or encephalopathy (an infection of the brain).
• Have a history of another type of cancer (except for skin cancer) before your diagnosis of NHL.
• Are allergic to etoposide or have had a toxic reaction to prior chemotherapy.

Sponsors & Collaborators

• Ribozyome: lead

Study Sites (1)

City of Hope Natl Med Ctr

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; HIV Infections; Lymphoma, AIDS-Related

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Lymphoma, B-Cell

Study Officials

• John Zaia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 2003-06

Locations

US (1)