Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

NCT ID: NCT00014560

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-28
• Study Completion Date: 2003-02-14

Brief Summary

RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Detailed Description

OBJECTIVES:

• Determine the maximum tolerated dose and dose-limiting toxicity of bispecific antibody 4G7xH22 in patients with relapsed or refractory non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
• Assess the clinical toxicity of this antibody in these patients.

OUTLINE: This is a dose escalation study of bispecific antibody (BsAb) 4G7xH22.

Patients receive sargramostim (GM-CSF) subcutaneously on day 1 and BsAb 4G7xH22 IV over 2 hours on day 2. Treatment repeats weekly for a total of 3 courses in the absence of unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of BsAb 4G7xH22 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.

Patients are followed weekly for 4 weeks, monthly for 3 months, and then periodically for 1 year.

PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study.

Conditions

Leukemia; Lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Antibody

Group Type: EXPERIMENTAL

bispecific antibody 4G7xH22

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

Interventions

bispecific antibody 4G7xH22

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC greater than 3,000/mm^3
• Platelet count greater than 100,000/mm^3
• Absolute neutrophil count greater than 1,500/mm^3

Hepatic:

• Bilirubin less than 1.5 mg/dL
• Alkaline phosphatase less than 2 times normal
• SGPT less than 2 times normal

Renal:

• Creatinine clearance greater than 50 mL/min

Other:

• No human-anti-murine-antibody response to prior murine monoclonal antibodies
• No immunological or inflammatory disease (e.g., lupus erythematosus)
• No active serious infection
• No other serious medical condition that would limit survival to less than 2 years
• No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
• No psychiatric or addictive disorder that would preclude study
• Not pregnant or nursing
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Prior immunotherapy allowed

Chemotherapy:

• See Disease Characteristics
• No concurrent chemotherapy

Endocrine therapy:

• Concurrent steroids for adrenal failure or adverse reactions to study drug allowed
• Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed

Radiotherapy:

• Not specified

Surgery:

• Not specified

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pamela Ely, MD

Role: STUDY_CHAIR

Norris Cotton Cancer Center

Locations

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

P30CA023108

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DMS-9806

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1936

Identifier Type: -

Identifier Source: secondary_id

CDR0000068556

Identifier Type: -

Identifier Source: org_study_id