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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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Phase I portion maximum tolerated dose (MTD) is defined as the dose level below the dose at which 2 out of 2-6 patients develop DLT (if any patient develops grade IV toxicity of any type (excluding grade IV neutropenia) or grade III non-hematologic toxicity that patient may not continue on the study at the same dose level and therefore has had a dose limiting toxicity). There can be no more than 1 out of 6 patients with DLT at the MTD. The MTD will be assessed using only the results from the fir

Interventions

  • BIOLOGICAL Y-90 Humanized Anti-Tac
  • DRUG Calcium-DTPA

Trial Details

FieldValue
Enrollment Target 87 participants
Start Date 1997-04
Est. Completion 2013-11
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00001575 record still lists

NCT00001575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% higher).

The record links to 0 conditions, and to 2 interventions - of which Y-90 Humanized Anti-Tac is the first listed.

NCT00001575 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00001575's enrollment target sits among peer trials

87 651st of 2000 higher than 1,349 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00001575, the US trial registry maintained by the National Library of Medicine. NCT00001575 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.