At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Study of HeFi-1 in Refractory CD30-Positive Malignancy
In Brief
A Phase 1 clinical trial evaluating HeFi-1 Monoclonal Antibody for Neoplasms. Completed, enrolled 9 participants across 2 sites.
Detailed Summary
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.