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Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003741
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
Information provided by:
National Cancer Institute (NCI)

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: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: monoclonal antibody HeFi-1 Phase 1

Detailed Description:


  • Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30+ anaplastic large cell lymphoma or Hodgkin's lymphoma.
  • Determine the pharmacokinetics of this drug in this patient population.
  • Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year.

Cohorts of 3-4 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 patients experience dose-limiting toxicity.

Patients are followed monthly.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study
Study Start Date : February 1999
Actual Study Completion Date : December 2007

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed CD30+ anaplastic large cell lymphoma (ALCL) or Hodgkin's lymphoma

    • At least 50% of malignant cells must react with HeFi-1
    • HIV positive or HIV negative
  • Measurable disease
  • No symptomatic CNS disease
  • Must have failed or be ineligible for standard chemotherapy regimen



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • More than 2 months


  • Not specified


  • No significant hepatic disease
  • Bilirubin no greater than 2 mg/dL


  • No significant renal disease
  • Creatinine no greater than 3 mg/dL


  • No significant cardiovascular disease


  • No significant pulmonary disease


  • No significant endocrine, rheumatologic, or allergic disease
  • No active clinical disease caused by cytomegalovirus (CMV), herpes simplex virus (HSV) I, HSV II, hepatitis B, or tuberculosis
  • Not pregnant
  • Fertile patients must use effective contraception


Biologic therapy:

  • No prior murine antibody therapy


  • See Disease Characteristics

Endocrine therapy:

  • Not specified


  • At least 4 weeks since prior radiotherapy to measurable disease


  • Not specified


  • At least 4 weeks since prior cytotoxic therapy to measurable disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003741

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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Study Chair: Henry Koon, MD Beth Israel Deaconess Medical Center
Layout table for additonal information Identifier: NCT00003741    
Other Study ID Numbers: BIDMC-97127
CDR0000066859 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: March 2005
Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
anaplastic large cell lymphoma
Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs