Completed

A Phase I Trial of Recombinant Vaccinia Virus That Expresses DF3/MUC1 in Patients With Metastatic Adenocarcinoma of the Breast

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What is being tested

rV-DF3/MUC1

Biological
Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: March 1999
See protocol details

Summary

Principal SponsorDana-Farber Cancer Institute
Last updated: February 15, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: March 3, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Determine the toxicity associated with repeated vaccination with recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) in patients with metastatic breast cancer. II. Determine the maximum tolerated dose of rV-DF3/MUC1, based on cellular and humoral immunity, in these patients. III. Determine whether vaccination with rV-DF3/MUC1 is associated with antitumor activity in these patients. OUTLINE: This is an open label, dose escalation study. Patients receive recombinant vaccinia DF3/MUC1 vaccine (rV-DF3/MUC1) intradermally. Treatment repeats every month for 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of at least 6 patients receive escalating doses of rV-DF3/MUC1 until the maximum tolerated dose (MTD) or the highest dose level to be tested is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6 months. PROJECTED ACCRUAL: A total of 16-28 patients will be accrued for this study within 1-2 years.

NCT00003761
Principal SponsorDana-Farber Cancer Institute
Last updated: February 15, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

Criteria

4 exclusion criteria prevent from participating
Patients must not have any other serious medical condition which in the opinion of the investigator is incompatible with the protocol. Patients with active infections requiring antibiotics are not eligible until the infection has cleared and the antibiotics have been stopped for at least 3 days
Patients must not have evidence of altered immune responsiveness or autoimmune syndromes (scleroderma, systemic lupus erythematosus, etc.). Patients must be HIV negative This treatment may be associated with increased adverse effects for individuals with immune deficiencies, and HIV-associated symptoms preclude accurate assessment of toxicity
Patients must not have undergone splenectomy
Patients with active cases or history of extensive skin disorders (such as extensive psoriasis, burns, impetigo, disseminated zoster) are ineligible

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
rV-DF3/MUC1 vaccinations will be administered 4 week intervals for a total of 3 doses. Participants will be followed weekly until 28 days after the final dose (day 85) then month for 6 months

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Massachusetts General Hospital Cancer Center

Boston, United StatesOpen Massachusetts General Hospital Cancer Center in Google Maps

Brigham and Women's Hospital

Boston, United States

Dana-Farber Cancer Institute

Boston, United States

Boston Medical Center

Boston, United States
Completed4 Study Centers