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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
apolizumab
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 6, 2003
Last Updated
May 14, 2013
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00055783
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Recurrent Hodgkin's Lymphoma
Official Title
A Phase II Study of Hu1D10 in Recurrent Hodgkin's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2003
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent adult Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
apolizumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra J. Horning, MD
Organizational Affiliation
Stanford University
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5408
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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