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NCT00048880 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of HeFi-1 to Treat Cancers With CD30 Protein
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00048880: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00048880 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00048880, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study 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.
Interventions
- DRUG HeFi-1 Monoclonal Antibody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2002-11-05 |
| Est. Completion | 2008-07-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00048880
The ClinicalTrials.gov registry entry for NCT00048880 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HeFi-1 Monoclonal Antibody is the first listed.
NCT00048880 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00048880 about?
NCT00048880 is a clinical study titled "Phase I Study of HeFi-1 to Treat Cancers With CD30 Protein". 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...
What is the current status of trial NCT00048880?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2002-11-05. Estimated completion is 2008-07-02.
What interventions are being tested in trial NCT00048880?
The interventions under investigation include: HeFi-1 Monoclonal Antibody (DRUG).
Who is sponsoring clinical trial NCT00048880?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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