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Monoclonal Antibody Therapy in Treating Patients With Recurrent Hodgkin's Lymphoma

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 6, 2003
Last updated: May 14, 2013
Last verified: April 2003

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

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have progressive or recurrent Hodgkin's lymphoma.

Condition Intervention Phase
Lymphoma Biological: apolizumab Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Hu1D10 in Recurrent Hodgkin's Disease

Resource links provided by NLM:

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

Study Start Date: July 2002
Study Completion Date: April 2003
Detailed Description:


  • Determine the response rate of patients with recurrent Hodgkin's lymphoma treated with monoclonal antibody Hu1D10.
  • Determine the duration of response and progression-free survival of patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody Hu1D10 IV over 2 hours. Treatment repeats weekly for a total of 4 doses in the absence of disease progression or unacceptable toxicity.

Patients are followed at weeks 5 and 8 and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within approximately 12 months.


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


  • Histologically confirmed Hodgkin's lymphoma
  • Progressive or recurrent disease after standard initial therapy
  • At least 1 unidimensionally measurable lesion (at least 15 mm by conventional techniques)
  • Patients in first relapse must be ineligible or unwilling to receive high-dose therapy and stem cell transplantation
  • Evidence of Hu1D10 localization to Reed Sternberg cells by immunohistochemistry
  • No known brain metastases



  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 6 months


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin normal
  • AST and ALT no greater than 2.5 times upper limit of normal


  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • No known human anti-human antibody
  • No prior allergic reaction to compounds of similar chemical or biological composition to monoclonal antibody Hu1D10
  • No ongoing or active infection
  • No other uncontrolled concurrent illness
  • No psychiatric illness or social situation that would preclude study compliance


Biologic therapy

  • See Disease Characteristics
  • See Chemotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Prior second-line (or greater) high-dose therapy and stem cell transplantation allowed

Endocrine therapy

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered


  • Not specified


  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
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Please refer to this study by its identifier: NCT00055783

United States, California
Stanford University Medical Center
Stanford, California, United States, 94305-5408
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Study Chair: Sandra J. Horning, MD Stanford University
  More Information Identifier: NCT00055783     History of Changes
Other Study ID Numbers: SUMC-NCI-1951
CDR0000271198 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: March 6, 2003
Last Updated: May 14, 2013

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on June 23, 2017