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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Lymphoma

Treatments: Biological: apolizumab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00055783

SUMC-NCI-1951

CDR0000271198 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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