Monoclonal Antibody Therapy in Treating Patients With Advanced Cancer

March 12, 2010 updated by: University of Arizona

A Phase IA Trial of Combined Murine IgG Monoclonal Anti-Transferrin Receptor Antibodies E2.3 and A27.15 in Cancer Patients

RATIONALE: Monoclonal 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 monoclonal antibodies in treating patients who have advanced cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the toxicities associated with a 4-hour infusion of antitransferrin receptor antibodies with one antibody administered by itself for 1 hour before the second antibody infusion is started. II. Determine the pharmacokinetics of monoclonal antibodies E2.3 and A27.15.

OUTLINE: This is a dose escalating study. Patients receive antitransferrin antibody A27.15 IV over 4 hours. One hour after the initiation of the A27.15 infusion, infusion of antibody E2-3 is added by IV piggy back. In the absence of antimouse antibodies and toxic effects, treatment continues once every 4 weeks in patients achieving minimal, partial, or complete remission. Treatment ceases in patients experiencing stable or progressive disease. In the absence of dose limiting toxicity in the first 3 patients treated, subsequent cohorts of 6 patients each receive escalating doses of antitransferrin antibodies E2.3 and A27.15 on the same dose schedule. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the MTD. Patients are followed for 3 weeks.

PROJECTED ACCRUAL: This study will accrue 18-27 patients within 2 years.

Study Type

Interventional

Enrollment (Anticipated)

27

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
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center

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: Refractory or recurrent advanced malignancy following known standard effective therapy or advanced malignancy for which no standard effective therapy exists Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count at least 1800/mm3 Hematocrit at least 30 mg/dL Platelet count at least 50,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal unless due to disease, then less than 3.5 times normal Transaminases less than 3 times upper limit of normal (ULN) (less than 5 times ULN if due to liver metastases) Renal: Creatinine no greater than 2.5 times normal Cardiovascular: No severe cardiac abnormalities Must have adequate venous access No history of sustained ventricular arrhythmia or unexplained syncope Pulmonary: No severe pulmonary abnormalities Other: Not pregnant or nursing Effective contraception required of fertile female patients No serious concurrent medical or psychiatric illness Adequate nutrition No human antimouse antibodies

PRIOR CONCURRENT THERAPY: At least 4 weeks since prior anticancer therapy and recovered If there was disease progression during therapy, at least 2 weeks since prior anticancer therapy and recovered Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy Endocrine therapy: Concurrent topical steroids used in the chronic management of cutaneous T cell lymphoma allowed No other concurrent hormone therapy Radiotherapy: No concurrent palliative radiotherapy Surgery: Not specified

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

University of Arizona

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael Lobell, MD, University of Arizona

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

December 1, 1997

Primary Completion (Actual)

February 1, 2001

Study Completion (Actual)

February 1, 2001

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 16, 2004

First Posted (Estimate)

July 19, 2004

Study Record Updates

Last Update Posted (Estimate)

March 16, 2010

Last Update Submitted That Met QC Criteria

March 12, 2010

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065781
  • P30CA023074 (U.S. NIH Grant/Contract)
  • UARIZ-HSC-95178
  • NCI-T96-0025

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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