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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.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Radiolabeled Monoclonal Antibody Therapy in Treating Adult Patients Who Have Recurrent Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Official Title  Phase I/II of Tac-Expressing Malignancies [Other Than ATL] With Yttrium-90 (90-Y)-Radiolabeled Humanized Anti-Tac and Calcium-DTPA
Brief Summary

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.

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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure  Response rate after completion of treatment [ Designated as safety issue: No ]
Secondary Outcome Measure  Survival at 2 years [ Designated as safety issue: No ]
Condition  Lymphoma
Radiation Toxicity
Intervention  Drug: daclizumab
Drug: pentetic acid calcium
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  55
Start Date  April 1997
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00019305
Organization ID CDR0000065530
Secondary IDs †† NCI-97-C-0110Q
Study Sponsor  National Cancer Institute (NCI)
Collaborators ††
Investigators 
Study Chair:     Thomas A. Waldmann, MD     NCI - Metabolism Branch;MET    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2008
First Received Date  July 11, 2001
Last Updated Date May 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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