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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), April 2008

Sponsored by: 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
Radiation Toxicity
Drug: daclizumab
Drug: pentetic acid calcium
Phase I
Phase II

MedlinePlus related topics:   Cancer    Hodgkin's Disease    Lymphoma   

ChemIDplus related topics:   Calcium gluconate    Pentetic acid    Calcium DTPA    Calcium trisodium pentetate    Zinc-DTPA    Dacliximab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   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

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:   55
Study Start Date:   April 1997
Estimated Primary Completion Date:   December 2008 (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. On day 42 the treatment course may be repeated at the same dosage level.

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 55 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)
  • Must meet the following disease specific criteria:

    • Non-Hodgkin's lymphoma (NHL)

      • Indolent stages II-IV that failed at least one standard therapy and requiring treatment
      • Aggressive NHL that relapsed after standard chemotherapy, and not eligible for or refused salvage chemotherapy or bone marrow transplantation
    • Hodgkin's lymphoma

      • 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
    • Cutaneous T-cell lymphoma

      • Stages Ib-III that failed at least one standard therapy
      • Stage IV eligible regardless of prior therapy
    • Peripheral T-cell lymphoma

      • Stages I-IV that relapsed after first line chemotherapy, and not eligible for or refused salvage chemotherapy or bone marrow transplantation
    • Other lymphoid leukemia or lymphoma

      • Failed standard therapy 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 chronic anticoagulant therapy
  • No prior bone marrow or stem cell transplantation

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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000065530, NCI-97-C-0110Q
First Received:   July 11, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00019305
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma  
stage IV cutaneous T-cell non-Hodgkin lymphoma  
recurrent cutaneous T-cell non-Hodgkin lymphoma  
recurrent grade 1 follicular lymphoma  
recurrent grade 2 follicular lymphoma  
recurrent grade 3 follicular lymphoma  
recurrent adult diffuse small cleaved cell lymphoma  
recurrent adult diffuse mixed cell lymphoma  
recurrent adult diffuse large cell lymphoma  
recurrent adult immunoblastic large cell lymphoma  
recurrent adult lymphoblastic lymphoma  
recurrent adult Burkitt lymphoma
recurrent adult T-cell leukemia/lymphoma
radiation toxicity
recurrent mantle cell lymphoma
stage IV mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Sezary syndrome
Hodgkin's disease
Hodgkin lymphoma, adult
Cutaneous T-cell lymphoma
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Sezary Syndrome
Lymphoma, B-Cell, Marginal Zone
Mycosis Fungoides
Lymphoma, large-cell, immunoblastic
Antibodies, Monoclonal
Lymphoma, large-cell
Lymphoma, B-Cell
Burkitt's lymphoma
Leukemia
Mycoses
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Hodgkin Disease
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Daclizumab
Leukemia, B-cell, chronic
Leukemia-Lymphoma, Adult T-Cell
Lymphoblastic lymphoma
Mantle cell lymphoma
Recurrence
Pentetic Acid

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Immunosuppressive Agents
Protective Agents
Pharmacologic Actions
Antidotes

ClinicalTrials.gov processed this record on August 28, 2008




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