Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors

July 17, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

A Phase I, Open Label Multiple Dose, Safety and Pharmacokinetic Study of Intravenously Administered Humanized Anti-VEGF Monoclonal Antibody (HuMV833) to Patients With Relapsed or Refractory Solid Tumors

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 antibody therapy in treating patients who have relapsed or refractory solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the preliminary tolerability and safety of monoclonal antibody VEGF (MOAB VEGF) in patients with relapsed or refractory progressive solid tumors. II. Determine the optimum biologically active dose of MOAB VEGF for further evaluation based on exploratory methods. III. Determine the maximum tolerated dose of MOAB VEGF in these patients. IV. Determine a safe dose of MOAB VEGF for further clinical studies. V. Determine the dose limiting toxicity and pharmacokinetics of this regimen in these patients. VI. Determine the response rate in patients treated with this regimen.

OUTLINE: This is a dose escalation, multicenter study. Patients receive monoclonal antibody VEGF (MOAB VEGF) IV over 1 hour on days 1, 15, 22, and 29. Patients with partial response (PR), complete response (CR), or stable disease (SD) after completion of the fourth dose may receive weekly infusions for up to 6 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of MOAB VEGF until the maximum tolerated dose (MTD) and optimum biologically active dose (OBAD) are determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose limiting toxicity. The OBAD is defined as the dose at which vascular endothelial growth factor is optimally inhibited. Patients with PR, CR, or SD are evaluated every 6 weeks until disease progression or initiation of another treatment. Patients who discontinue treatment prematurely due to toxicity are followed weekly until resolution of any associated toxicity. Patients who discontinue treatment after the fourth dose of MOAB VEGF for any reason other than toxicity are followed every month for up to 6 months.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

20

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

  • Netherlands
      • Maastricht, Netherlands, 6202 AZ
        • Academisch Ziekenhuis Maastricht
      • Utrecht, Netherlands, 3508 GA
        • Academisch Ziekenhuis Utrecht
  • Sweden
      • Linkoping, Sweden, S-581 85
        • University Hospital of Linkoping
  • United Kingdom
    • England
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital N.H.S. Trust

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 proven relapsed or refractory progressive solid tumor that is not amenable to treatment with standard therapies No brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Postmenopausal Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL No bleeding or clotting abnormalities Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST or ALT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: Normal cardiac function by 12 lead ECG Other: No unstable systemic disease or uncontrolled infection that would preclude study participation No concurrent infection requiring antibiotics Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 70 days after study No psychologic, familial, sociologic, or geographic condition that could preclude compliance HIV negative HTLV-1 negative Hepatitis B surface antigen negative No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix No allergy to protein therapeutics

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior hormonal antitumor therapy No concurrent steroids or hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Concurrent radiotherapy allowed Surgery: Greater than 4 weeks since prior surgery except biopsy or fine needle aspiration of tumor masses Other: At least 4 weeks since other prior investigational drugs or therapies No other concurrent anticancer treatments No other concurrent investigational therapy

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

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Gordon Jayson, MD, The Christie NHS Foundation Trust

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, 1999

Primary Completion (Actual)

June 1, 2001

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

April 9, 2004

First Posted (Estimate)

April 12, 2004

Study Record Updates

Last Update Posted (Estimate)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-13992
  • PDL-833-601

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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