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

NCT ID: NCT00055783

Last Updated: 2013-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-07-31
• Study Completion Date: 2003-04-30

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.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

apolizumab

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Principal Investigators

Sandra J. Horning, MD

Role: STUDY_CHAIR

Stanford University

Locations

Stanford University Medical Center

Stanford, California, United States

Countries

United States

Other Identifiers

CDR0000271198

Identifier Type: REGISTRY

Identifier Source: secondary_id

SUMC-NCI-1951

Identifier Type: -

Identifier Source: org_study_id