Monoclonal Antibody Therapy in Treating Patients With Recurrent or Refractory Lymphoma

NCT ID: NCT00007956

Last Updated: 2015-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30

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 I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent or refractory lymphoma.

Detailed Description

OBJECTIVES:

• Determine the maximum tolerated dose and dose-limiting toxicity of monoclonal antibody mono-dgA-RFB4 in patients with recurrent or refractory B-cell lymphoma expressing CD22 antigen.
• Determine the pharmacokinetic profile of this drug in these patients.
• Correlate the pharmacokinetic parameters with the biologic effects and/or toxicity of this drug in these patients.
• Determine whether clinical responses in these patients occur at lower, equal, or higher doses than historical responses induced by a similar drug.

OUTLINE: This is a dose-escalation study. Patients are stratified according to number of circulating tumor cells in peripheral blood (more than 50/mm3 vs 50/mm3 or less).

Patients receive monoclonal antibody Mono-dgA-RFB4 IV over 4 hours on days 1, 3, and 5. Patients achieving complete, partial, or minimal remission receive additional courses of therapy every 4 weeks in the absence of unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of monoclonal antibody mono-dgA-RFB4 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients achieving complete remission or stable partial remission are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-18 months.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

monoclonal antibody mono-dgA-RFB4

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Platelet count greater than 50,000/mm^3
• Absolute granulocyte count greater than 750/mm^3

Hepatic:

• Bilirubin less than 1.5 mg/dL
• SGPT less than 2 times upper limit of normal
• Albumin greater than 75% lower limit of normal

Renal:

• Creatinine no greater than 1.4 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• Ejection fraction greater than 40% by MUGA or echocardiogram

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No human anti-mouse antibody (HAMA) levels greater than 1 microgram/mL
• No condition that may require stenting of ureters, stabilization of impending pathological fractures, or relief of airway, bowel, or biliary tract obstruction
• No other concurrent illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics
• At least 2 weeks since prior chemotherapy and recovered
• No concurrent chemotherapy

Endocrine therapy:

• No concurrent corticosteroids unless receiving stable maintenance dose prior to therapy

Radiotherapy:

• No prior radiotherapy
• No concurrent radiotherapy

Surgery:

• Not specified

Other:

• No other concurrent investigational agents

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Edward A. Sausville, MD, PhD

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Center for Cancer Research

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-01-C-0021

Identifier Type: -

Identifier Source: secondary_id

UTSMC-99-02-07

Identifier Type: -

Identifier Source: secondary_id

CDR0000068356

Identifier Type: -

Identifier Source: org_study_id

NCT00006423

Identifier Type: -

Identifier Source: nct_alias