Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients With Limited Residual Disease After Surgery

August 12, 2021 updated by: Gilead Sciences

A Phase I, Single Dose Escalating Study to Investigate the Tolerability, Pharmacokinetics and Dosimetry of 90 Y-Humanized MN-14 IgG in Colorectal Cancer Patients With Limited Residual Disease After Primary or Salvage Surgery

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of residual colorectal cancer following recent surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

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
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical 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:

  • Patients with documented histologic and cytologic diagnosis of colon or rectal malignancy
  • Patients with documented status post surgical resection of primary cancer or metastases
  • Limited residual disease (i.e., CEA serum levels < 15 ng/mL and negative baseline CT scans, or no lesion > 1 cm)

Prior/Concurrent Therapy:

  • Patients must have completed chemotherapeutic agents, biologic therapy, radiotherapy, other investigational therapy for cancer, or surgical procedures at least six weeks prior to study entry.
  • Patients must have recuperated from surgery and toxicities (as a result of previous therapy) sufficiently prior to study entry
  • Biologic Therapy: Patients who have received a murine, chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN-14 IgG (i.e., HAHA)
  • Radiotherapy: No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organs (e.g., 3000 cGy for the liver; 2000 cGy for the lungs and kidneys)

Patient Characteristics/Inclusion Criteria:

  • Performance Status: Patients with Karnofsky performance status > 70%
  • Hematopoietic: ANC >/= 1.5 x 10/L; Hemoglobin >/= 10 g/dL; Platelets >/= 100 x 10/L
  • Renal: Serum Creatinine </= 1.5 x ULN
  • Hepatic: Serum Bilirubin </= 1.5 ULN; AST and ALT </= 2.5 x ULN; Alk Phosphatase </= 2.5 x ULN
  • Cardiovascular: Patients with LVEF >/= 50% by required MUGA/2D-ECHO tests
  • Pulmonary: Patients with DF and FEV1 >/= 60% by required Pulmonary Function Tests
  • Central Nervous System: Patients with known metastatic disease to the CNS are excluded.
  • Other: Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into study. Patients must understand and give written informed consent.

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
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Investigators

  • Study Chair: Lauri Welles, MD, Gilead Sciences
  • Study Director: Terence Rugg, MD, Gilead Sciences

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 7, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

July 12, 2002

First Submitted That Met QC Criteria

July 12, 2002

First Posted (Estimate)

July 15, 2002

Study Record Updates

Last Update Posted (Actual)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 12, 2021

Last Verified

January 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM-T-hMN14-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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