E1494 – Trial Results Summary for Patients

Title

Study of Continuous Infusion, Combination Chemotherapy in Patients with HIV-Associated Non-Hodgkin’s Lymphoma (A Phase II Trial)

Sponsor

Eastern Cooperative Oncology Group through the National Cancer Institute-sponsored Cancer Cooperative Group Program

Purpose of the Study

To determine the effectiveness of a chemotherapy infusion treatment using a combination of anti-cancer drugs: cyclophosphamide, doxorubicin, and etoposide (CDE) in patients with non-Hodgkin’s lymphoma associated with the human immunodeficiency virus (HIV). The study also evaluated survival rates and the side effects and infections that occurred after this treatment.

Results

Forty-six percent of patients had a complete response to treatment. Forty-nine percent were alive and 38 percent were alive without evidence of lymphoma at two years. During the course of the study in December 1996, highly active antiretroviral therapy (HAART) became standard treatment for patients with HIV infection. Patients treated after this time had improved survival, and were less likely to experience severe or life threatening complications associated with chemotherapy. The study showed that up to one-half of patients with HIV-associated lymphoma may be cured of the lymphoma with infusional chemotherapy. It also showed that the prognosis for HIV-associated lymphoma has significantly improved after HAART became commonly used for the management of HIV infection.

Conclusion

The study showed that up to one-half of patients with HIV-associated lymphoma may be cured of the lymphoma with infusional chemotherapy. It also showed that the prognosis for HIV-associated lymphoma has significantly improved after HAART became commonly used for the management of HIV infection. Additional studies are ongoing evaluating the role of infusional chemotherapy used alone or in conjunction with other lymphoma treatments, such as rituximab.

Start Date

January 1995

Stop Date

June 1999

Number of Participating Patients

113

Eligibility Requirements

Patients were at least 18 years old and had HIV-related non-Hodgkins lymphoma that could be measured or evaluated. They had no previous chemotherapy or radiation therapy and had received a protease inhibitor (which slows growth of virus cells) within one week of the trial.

Study Design

Patients received combination anti-cancer chemotherapy by continuous infusion into a blood vessel for four days, every four weeks for up to eight months. In order to give the chemotherapy in this manner, a tube was inserted into a blood vessel and the medication was delivered continuously over the four-day period. Patients also received antiviral medications to slow the growth of the HIV virus and other medications to prevent infections and other complications. Some patients also received additional chemotherapy and radiation therapy to treat or prevent lymphoma in the lining of the brain and in the spinal fluid.

Side Effects

The most frequent side effects were abnormalities in blood counts. Infections, including pneumonia, were experienced by 20 percent of participants, problems with metabolism (how the body processes chemicals to produce energy and support basic body functions) by 17 percent, liver problems and central nervous system problems (14 percent each) and mouth sores (11 percent). Five patients died as a result of complications related to treatment.

Additional Information at ClinicalTrials.gov

NCT00002905