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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055783
• Other study ID #: SUMC-NCI-1951
• Secondary ID: CDR0000271198
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2003
• Last updated: May 14, 2013
• Start date: July 2002
• Est. completion date: April 2003

Study information

• Verified date: April 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• apolizumab

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,