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Phase I/II Study of Tac-Expressing Malignancies Other Than Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Humanized Anti-Tac and Calcium-DTPA


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cutaneous T Cell Lymphoma, Hodgkin's Disease, Neoplasm, Non Hodgkin's Lymphoma, Peripheral T Cell Lymphoma

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Trial Information

Phase I/II Study of Tac-Expressing Malignancies Other Than Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Humanized Anti-Tac and Calcium-DTPA


Background:

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.

Inclusion 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 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 SGOT and 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 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 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Thomas A Waldmann, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

970110

NCT ID:

NCT00001575

Start Date:

April 1997

Completion Date:

Related Keywords:

  • Cutaneous T Cell Lymphoma
  • Hodgkin's Disease
  • Neoplasm
  • Non Hodgkin's Lymphoma
  • Peripheral T Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Cutaneous T-Cell Lymphoma (CTCL)
  • Peripheral T-Cell Lymphoma
  • Radiolabeled Antibody
  • Yttrium 90
  • Radiolabeled
  • Anti -Tac
  • Calcium DTPA
  • Neoplasms
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892