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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.
Study NCT00019305   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: July 7, 2009   History of Changes

July 11, 2001
July 7, 2009
April 1997
December 2009   (final data collection date for primary outcome measure)
Response rate after completion of treatment [ Designated as safety issue: No ]
Response rate after completion of treatment
Complete list of historical versions of study NCT00019305 on ClinicalTrials.gov Archive Site
Survival at 2 years [ Designated as safety issue: No ]
Survival at 2 years
 
Radiolabeled Monoclonal Antibody Therapy in Treating Adult Patients Who Have Recurrent Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma
Phase I/II of Tac-Expressing Malignancies [Other Than ATL] With Yttrium-90 (90-Y)-Radiolabeled Humanized Anti-Tac and Calcium-DTPA

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.

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.

Phase I, Phase II
Interventional
Treatment
Lymphoma
  • Biological: daclizumab
  • Drug: pentetic acid calcium
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
90
 
December 2009   (final data collection date for primary outcome measure)

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 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
Both
18 Years and older
No
 
United States
 
NCT00019305
Thomas A. Waldmann, NCI - Metabolism Branch;MET
CDR0000065530, NCI-97-C-0110
National Cancer Institute (NCI)
 
Study Chair: Thomas A. Waldmann, MD NCI - Metabolism Branch;MET
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP