Phase I Study of HeFi-1 to Treat Cancers With CD30 Protein

Completed · Phase 1

Conditions studied: Neoplasms

In brief

Background: * Some cancers, such as Hodgkin's disease, anaplastic large cell lymphoma and others, have a protein on the surface of the cancer cell called CD30. * HeFi-1 is an antibody that binds to the CD30 protein and sends signals to the cancer cells that can cause them to die. Objectives: * To determine the highest dose of HeFi-1 that can safely be given to patients with tumors that have the CD30 protein. * To determine the response of the tumor to treatment with HeFi-1. Eligibility: * Patients 18 years of age and older with Hodgkin's disease, anaplastic large cell lymphoma, cutaneous T cell lymphoma and adult T cell leukemia or lymphoma who have signs of tumor growth or recurrence following standard treatment * Patients' tumor cells must have the CD30 protein. Design: * Groups of three patients are treated with increasingly higher doses of HeFi-1 (ranging from 0.5 to 5 mg/kg) to determine the highest safe dose. * HeFi-1 is infused through a vein on 4 days, followed by 2 days of rest over a 10-day period. Patients may receive up to 2 treatment courses if they show some response and do not have severe side effects. * Blood samples are collected several times during the study to determine safety. A lymph node biopsy is done at the beginning of the study to test the effect of HeFi-1 on cancer cells in the test tube, and a bone marrow biopsy may be done at the end of treatment if the bone marrow was positive for tumor cells at the beginning of treatment.

Key facts

Study ID

NCT00048880

Run by

National Cancer Institute (NCI)

People needed

9

Starts

2002-11-05

Expected to finish

2008-07-02

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients with central nervous system disease as assessed by clinical examination. If the clinical findings suggest the presence of CNS disease a lumbar puncture should be done.
• Pregnant and nursing patients are not eligible for the study because the effects of HeFi-1 on the developing fetus and the nursing infant are unknown. All patients must agree to use effective contraceptive measures while receiving therapy and for two weeks afterwards.
• HIV positive patients are excluded from the study because the toxicity may be different in this population.
• Hepatitis B surface antigen positive and Hepatitis C antibody positive patients are excluded because the toxicity of therapy may be different in this population.
• Patients who previously received murine monoclonal antibody therapy are ineligible.
• Patients who are HAMA positive.
• Patients with significant renal, pulmonary, cardiovascular, endocrine, rheumatologic or allergic disease should be excluded.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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