Search / Trial NCT00001575

Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

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Trial Information

Current as of June 13, 2024

Completed

Keywords

Yttrium 90 Radiolabeled Anti Tac Calcium Dtpa

Description

Background: Cluster of differentiation 25 (CD25) is expressed on the malignant cells of patients with certain lymphoid malignancies as well as the non-malignant T cells that surround the malignant tumor cells of patients with Hodgkin's disease. Zenapax is a humanized monoclonal antibody that binds to CD25. Zenapax has been chemically modified by the addition of a chelating molecule to permit binding of radioactive yttrium. The yttrium labeled Zenapax binds to CD25 to deliver radiation treatment to the tumor. Objective: To assess the toxicity and therapeutic efficacy of (90)Yttrium-lab...

Gender

All

Eligibility criteria

  • INCLUSION CRITERIA:
  • All patients must have a histologically confirmed diagnosis of Hodgkin's disease. Patients who have had an allogeneic or autologous transplant are eligible if they are more than 100 days post-transplant.
  • At least 10% of each patient's malignant cells from peripheral blood, lymph node, skin, or other extranodal sites must react with anti-Tac, as determined by immunofluorescent or immunoperoxidase staining. Because of the high incidence of Tac positivity in infiltrating T cells in Hodgkin's disease, patients with cluster of differentiation 25 (CD25) positive infiltrating T cells will be eligible even if the Hodgkin's cells are negative.
  • Diagnoses and Stage Disease: 1) Non-Hodgkin's Lymphoma (NHL): Patients with all histopathologic subtypes of Tac-expressing NHL are eligible. Patients with indolent NHL Stages II through IV are eligible if they have failed at least one standard therapy and have disease requiring treatment. Patients with aggressive NHL are eligible if they have relapse after standard chemotherapy and either are not eligible for or have refused salvage chemotherapy or bone marrow transplantation.
  • 2) Hodgkin's disease: Patients who are considered to have a low potential for cure with conventional chemotherapy or radiation therapy are eligible. Specifically, patients with stages II-IV Hodgkin's disease are eligible if they have relapsed or failed to attain a complete remission after first-line chemotherapy and either are not eligible for or have refused salvage chemotherapy or bone marrow transplantation.
  • 3) Cutaneous T-cell Lymphoma (CTCL): Patients with all stages of Tac-expressing CTCL are eligible with the exception of Stage Ia. Patients with Stages Ib through III are eligible if they have failed at least one standard therapy. Patients with stage IV are eligible regardless of whether they have had previous therapy.
  • 4) Peripheral T-cell Lymphoma (PTCL): Patients with stages I - IV PTCL are eligible if they have relapsed after first-line chemotherapy and either are not eligible for or have refused salvage chemotherapy or bone marrow transplantation.
  • Other: Patients with lymphoid leukemias or lymphomas not easily classified in the above categories will be eligible providing they have failed standard therapy and are not eligible for or have refused bone marrow transplantation.
  • Patients must have a Karnofsky performance status of at least 50.
  • Patients must have a creatinine of less than 2.0 mg/dl. If they patient has an abnormally elevated creatinine a creatinine clearance must be greater than 50 ml/min.
  • Patients must have serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) less than 5 times the upper limit of normal, bilirubin less than 3.0 unless this is felt to be due to the malignancy.
  • Patients must not have clinical cardiac failure. Patients with symptomatic pulmonary dysfunction are eligible only if it is due to the underlying malignancy.
  • The patient must have a granulocyte count of at least 1,200/mm^3 and a platelet count of greater than 100,000/mm^3.
  • Patients must be able to understand and sign informed consent.
  • Breast-feeding females are not eligible for the study.
  • Omission of cytotoxic chemotherapy or other systemic therapy of the malignancy for 3 weeks prior to entry into trial. However, patients receiving corticosteroids will not be excluded. Patients receiving corticosteroids must be on a stable dose for at least three weeks before receiving yttrium 90-labeled humanized anti-Tac (90Y-HAT) on this study.
  • Patients must have a life expectancy of greater than 1 month.
  • Patients must be at least 18 years old.
  • EXCLUSION CRITERIA:
  • Female patients of child bearing potential will be tested for pregnancy; pregnant patients will be excluded from the study.
  • Patients who are human immunodeficiency virus (HIV) antibody positive.
  • Patients with symptomatic disease that is due to malignant involvement of the central nervous system.
  • Patients with active second primary cancer.
  • Patients receiving chronic anticoagulant therapy will be excluded from the study.
  • Patients requiring urgent chemotherapy or radiation therapy for management of their malignancy will be excluded.
  • Patients with evidence of myelodysplastic syndrome or chromosomal abnormalities in their screening bone marrow evaluation

Attachments

readout_NCT00001575_2024-06-13.pdf

4.5 MB

NCT00001575_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Patients could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks.

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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