Gene Therapy + Chemotherapy for AIDS-Related Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byAmrita Krishnan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This pilot clinical trial studies gene therapy following combination chemotherapy in treating patients with acquired immune deficiency syndrome (AIDS)-related non-Hodgkin lymphoma. Placing genes that have been shown in the laboratory to inhibit the growth and spread of the immunodeficiency virus (HIV) into the patient's peripheral blood stem cells may improve the body's ability to fight HIV. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving gene therapy after combination chemotherapy may improve the body's ability to fight HIV and AIDS-related non-Hodgkin lymphoma.

Eligibility Criteria

This trial is for HIV-positive patients with specific types of AIDS-related non-Hodgkin lymphoma, who have not had other cancers (except certain skin cancers or those treated curatively over 2 years ago), no history of severe brain conditions or seizures, and are not pregnant. They must be able to follow the study plan, use effective birth control, and show a significant reduction in their lymphoma after initial chemotherapy.

Inclusion Criteria

My kidney function is within the required range for the study.

I am HIV positive and will receive standard HIV treatment during the study.

My lymphoma is confirmed by biopsy and suitable for R-EPOCH treatment.

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Exclusion Criteria

I do not have any uncontrolled illnesses or active infections, except for HIV.

I am not currently on any experimental treatments or other cancer therapies.

Any AIDS-related opportunistic infection occurring within the past year and for which treatment has been unsuccessful would be considered exclusionary, but this is done on a case-by-case basis as determined by the principal investigator (PI)

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Participant Groups

The trial tests gene therapy combined with chemotherapy in AIDS-related non-Hodgkin lymphoma patients. It involves inserting genes that may inhibit HIV into stem cells after standard chemo drugs like rituximab and doxorubicin. The goal is to see if this can boost the body's fight against both cancer and HIV.

1Treatment groups

Experimental Treatment

Group I: Treatment (R-EPOCH, rHIV7-shI-TAR-CCR5RZ-transduced HSPC)Experimental Treatment8 Interventions

Patients receive prednisone PO BID on days 1-5; rituximab IV on day 1; etoposide IV over 96 hours, doxorubicin hydrochloride IV over 96 hours and vincristine sulfate IV over 96 hours on days 1-4; and cyclophosphamide IV over 30-60 minutes on day 5. Patients then receive filgrastim SC QD beginning on day 6 and continuing until absolute neutrophil count recovers. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic stem/progenitor cells IV on day 0 (48 hours after the final combination chemotherapy course.)