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Radiolabeled Monoclonal Antibody Therapy in Treating Adult Patients Who Have Recurrent Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: July 11, 2001   Last Updated: February 4, 2010   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019305
  Purpose

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of radiolabeled monoclonal antibody when given together with pentetic acid calcium and to see how well they work in treating patients with recurrent Hodgkin's lymphoma or non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: daclizumab
Drug: pentetic acid calcium
Phase I
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I/II of Tac-Expressing Malignancies [Other Than ATL] With Yttrium-90 (90-Y)-Radiolabeled Humanized Anti-Tac and Calcium-DTPA

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate after completion of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival at 2 years [ Designated as safety issue: No ]

Estimated Enrollment: 95
Study Start Date: April 1997
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Assess the toxicity and therapeutic efficacy of yttrium Y 90 radiolabeled humanized anti-Tac (HAT) monoclonal antibody in patients with Tac expressing hematologic malignancies.
  • Define the pharmacokinetics of indium In 111 and yttrium Y 90 HAT monoclonal antibodies.

OUTLINE: This is a dose-escalation study.

Patients are given yttrium Y 90 labeled humanized anti-Tac monoclonal antibody (Y-HAT) according to an escalating dose schedule along with a fixed dose of pentetic acid calcium (Ca-DTPA) and indium In 111 labeled humanized anti-Tac monoclonal antibody (In-HAT). On day 1, Y-HAT and In-HAT are administered IV over 2 hours followed by a 5-hour infusion of Ca-DTPA. Additional 5-hour infusions of Ca-DTPA are given on days 2 and 3. Treatment may repeat every 6 weeks for up to 7 courses.

Cohorts of 3 to 6 patients are enrolled at each dose level. Dose escalation continues until the maximum-tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity. After the MTD is defined the phase II portion of the study begins.

PROJECTED ACCRUAL: Approximately 65 patients will be accrued in phase I and an additional 30 patients in phase II.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed Hodgkin's lymphoma, non-Hodgkin's lymphoma, or lymphoid leukemia with at least 10% of malignant cells reacting with anti-Tac monoclonal antibody (waived for Hodgkin's lymphoma)

    • Hodgkin's lymphoma meeting the following criteria:

      • Stages II-IV that relapsed or failed to achieve complete remission after first line chemotherapy, and not eligible for or refused salvage chemotherapy or bone marrow transplantation

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 50-100%

Life expectancy:

  • Greater than 1 month

Hematopoietic:

  • Granulocyte count at least 1,200/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • SGOT and SGPT less than 5 times upper limit of normal (ULN)
  • Bilirubin less than 3 times ULN

Renal:

  • Creatinine less than 2.0 mg/dL OR
  • Creatinine clearance greater than 50 mL/min

Cardiovascular:

  • No clinical evidence of cardiac failure

Pulmonary:

  • No symptomatic pulmonary dysfunction unless due to malignancy

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • HIV negative
  • No active second primary malignancy other than basal cell skin cancer
  • No symptomatic disease due to CNS involvement

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No anticoagulant therapy

Chemotherapy:

  • At least 3 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • Corticosteroids allowed if dose is stable for at least 3 weeks

Radiotherapy:

  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019305

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Study Chair: Thomas A. Waldmann, MD NCI - Metabolism Branch;MET
  More Information

Additional Information:
No publications provided

Responsible Party: NCI - Metabolism Branch;MET ( Thomas A. Waldmann )
Study ID Numbers: CDR0000065530, NCI-97-C-0110
Study First Received: July 11, 2001
Last Updated: February 4, 2010
ClinicalTrials.gov Identifier: NCT00019305     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
recurrent small lymphocytic lymphoma
splenic marginal zone lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
stage IV mycosis fungoides/Sezary syndrome

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Daclizumab
Physiological Effects of Drugs
Iron Chelating Agents
Immunosuppressive Agents
Protective Agents
Pharmacologic Actions
Pentetic Acid
Lymphatic Diseases
Neoplasms
Chelating Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma
Antidotes

ClinicalTrials.gov processed this record on March 18, 2010