Monoclonal Antibody Therapy in Treating Patients With Recurrent or Refractory Lymphoma

April 29, 2015 updated by: National Cancer Institute (NCI)

A Phase I Study Of Therapy With Mono-dgA-RFB4 In Patients With Relapsed And Refractory CD22+ B-Cell Lymphoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
      • Bethesda, Maryland, United States, 20892
        • Center for Cancer Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent or refractory B-cell lymphoma after at least 1 standard chemotherapy regimen

    • Low, intermediate, or high grade
    • CD22 antigen on at least 30% of tumor cells by flow cytometry
  • No lymphoblastic lymphoma, B-cell chronic lymphocytic leukemia, B-cell or pre-B-cell acute lymphocytic leukemia, or hairy cell leukemia

  • Measurable disease

    • Positive bone marrow not considered measurable
    • Circulating tumor cells in peripheral blood considered measurable
  • No CNS disease (leptomeningeal or parenchymal)
  • No lymphomatous or infectious pulmonary parenchymal disease
  • No baseline/pleural effusion
  • Ineligible for or refused autologous or allogeneic bone marrow transplantation NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Edward A. Sausville, MD, PhD, National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Study Registration Dates

First Submitted

January 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

February 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068356
  • NCI-01-C-0021
  • UTSMC-99-02-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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