Completed

Therapeutic Efficacy of (90)Yttrium-labeled Anti-Tac in CD25 Positive Lymphoid Malignancies

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Study Aim

This study aims to determine the maximum tolerated dose and evaluate the clinical response of (90)Yttrium-labeled Anti-Tac in treating CD25 positive lymphoid malignancies.

What is being tested

Y-90 Humanized Anti-Tac Treatment

+ Clearing Radioactive Agent with Calcium-DTPA

BiologicalDrug
Who is being recruted

Hemic and Lymphatic Diseases+7

+ Immune System Diseases

+ Immunoproliferative Disorders

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: April 1997
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: December 7, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 1997

Actual date on which the first participant was enrolled.

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-labeled humanized anti-Tac((90)Y-HAT) in patients with Tac-expressing hematologic malignancies. To determine the sites of localization of radiolabeled Zenapax. Eligibility: Patients with Hodgkin's disease and other CD25 positive lymphoid malignancies. The patient must have a granulocyte of at least 1,200/mm^3 and a platelet count of greater than 100,000/mm^3. Design: Patients will be treated with 10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled Zenapax. Indium labeled Zenapax is given to demonstrate the antibody distribution and confirm localization at sites of tumor. Treatment is given every six weeks if tolerated and patients will be hospitalized for about one week for each treatment. Tumor response will be evaluated after every treatment. Stable or responding patients will continue treatment with evaluations after every cycle of treatment. Patients will be treated for up to seven cycles.

Principal SponsorNational Cancer Institute (NCI)
Last updated: December 7, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

87 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeHodgkin DiseaseLymphoma, Non-Hodgkin

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA). Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center