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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003741
First Posted: January 27, 2003
Last Update Posted: June 26, 2013
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.
Information provided by:
National Cancer Institute (NCI)
November 1, 1999
January 27, 2003
June 26, 2013
February 1999
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Complete list of historical versions of study NCT00003741 on ClinicalTrials.gov Archive Site
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Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma
HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study

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.

OBJECTIVES:

  • 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.

Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma
Biological: monoclonal antibody HeFi-1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2007
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • More than 2 months

Hematopoietic:

  • Not specified

Hepatic:

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

Renal:

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

Cardiovascular:

  • No significant cardiovascular disease

Pulmonary:

  • No significant pulmonary disease

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior murine antibody therapy

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy to measurable disease

Surgery:

  • Not specified

Other

  • At least 4 weeks since prior cytotoxic therapy to measurable disease
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003741
BIDMC-97127
CDR0000066859 ( Registry Identifier: PDQ (Physician Data Query) )
NEDH-97127
NCI-870
NCI-V99-1515
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Beth Israel Deaconess Medical Center
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Study Chair: Henry Koon, MD Beth Israel Deaconess Medical Center
National Cancer Institute (NCI)
March 2005

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