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

May 14, 2013 updated by: Stanford University

A Phase II Study of Hu1D10 in Recurrent Hodgkin's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305-5408
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 6 months

Hematopoietic

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

Hepatic

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

Renal

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

Cardiovascular

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • See Chemotherapy

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

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered

Surgery

  • Not specified

Other

  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (ACTUAL)

April 1, 2003

Study Registration Dates

First Submitted

March 6, 2003

First Submitted That Met QC Criteria

March 6, 2003

First Posted (ESTIMATE)

March 7, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

April 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUMC-NCI-1951
  • CDR0000271198 (REGISTRY: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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