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NCT00001575 · ClinicalTrials.gov registry record · Phase 1
Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 87
- Enrollment target
NCT00001575: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001575 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 87 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001575, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 87 participants
- Enrollment target
Study Summary
This study will examine the use of a radioactive monoclonal antibody called yttrium 90-labeled humanized anti-Tac (90 Y-HAT) for treating certain cancers. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. The anti-Tac antibody in this study is targeted to tumor cells and is tagged (labeled) with a radioactive substance called Yttrium-90 (Y-90). The study will determine the maximum tolerated dose of 90Y-HAT and examine its safety and effectiveness. Patients 18 years of age and older with Hodgkin's disease, non-Hodgkin's lymphoma and lymphoid leukemia who have proteins on their cancer cells that react with anti-Tac may be eligible for this study. Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (EKG), chest x-ray, computed tomography (CT) scan or ultrasound of the abdomen, positron emission tomography (PET) scan of the neck and body, and skin test for immune reactivity to antigens (similar to skin tuberculin test). Before beginning treatment, participants may undergo additional procedures, including the following: * Patients with suspicious skin lesions have a skin biopsy. An area of skin is numbed and a circular piece of skin about 1/4-inch diameter is removed with a cookie cutter-like instrument. * Patients with hearing loss have a hearing test. * Patients with neurological symptoms have a lumbar puncture (spinal tap). A local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. * Patients who have not had a bone marrow biopsy within 6 months of screening also undergo this procedure. The skin and bone at the back of the hip are numbed with a local anesthetic and a small piece of bone is withdrawn through a needle. Patients receive 90 Y-HAT in escalating do
Interventions
- BIOLOGICAL Y-90 Humanized Anti-Tac
- DRUG Calcium-DTPA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 1997-04 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001575
The ClinicalTrials.gov registry entry for NCT00001575 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 87 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 2 interventions - of which Y-90 Humanized Anti-Tac is the first listed.
NCT00001575 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001575 about?
NCT00001575 is a clinical study titled "Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia". This study will examine the use of a radioactive monoclonal antibody called yttrium 90-labeled humanized anti-Tac (90 Y-HAT) for treating certain cancers. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. The anti-T...
What is the current status of trial NCT00001575?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 87 participants. The study started on 1997-04. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00001575?
The interventions under investigation include: Y-90 Humanized Anti-Tac (BIOLOGICAL), Calcium-DTPA (DRUG).
Who is sponsoring clinical trial NCT00001575?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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