BN Brachyury and Radiation in Chordoma



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:12 - 99
Updated:2/14/2019
Start Date:October 31, 2018
End Date:January 2021

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A Phase 2 Trial of BN-Brachyury and Radiation Therapy in Patients With Advanced Chordoma

This goal of this study is to determine if the combination of BN-Brachyury plus radiation
therapy can induce objective radiographic response rate (ORR) in patients, using a Simon
2-stage optimal design. In stage 1, a minimum of threshold of activity will be needed to
proceed to stage 2.


Inclusion Criteria:

- Patients must have histologically confirmed chordoma

- Patients must have measurable disease by RECIST 1.1

- Patients must be scheduled to have radiation therapy to at least 1 target lesion.

- Age ≥12 years

- Patients must have normal organ and marrow function

- Must have recovered completely from any reversible toxicity associated with recent
therapy.

- There should be a minimum of 2 weeks from any chemotherapy, small molecule/targeted
therapy, immunotherapy and/or radiation prior to enrolment

- Females of childbearing potential and male partners of Females of childbearing
potential must agree to use effective birth control or abstinence from screening to
after the last vaccination therapy

Exclusion Criteria:

- Concurrent treatment for cancer, with specific exceptions noted in the inclusion
criteria

- Chronic hepatitis B or C infection.

- Any significant disease, that in the opinion of the investigator may impair the
patient's tolerance of trial treatment.

- Significant dementia, altered mental status, or any psychiatric condition that would
prohibit the understanding, or rendering of informed consent.

- Active autoimmune diseases requiring treatment or a history of autoimmune disease that
might be stimulated by vaccine treatment. This requirement is due to the potential
risks of exacerbating autoimmunity.

- Concurrent use of systemic steroids, except for physiological doses of systemic
steroid replacement or local steroid use.

- Patients who are receiving any other investigational agents within 28 days before
start of trial treatment.

- History of allergic reactions attributed to compounds of similar chemical or
biological composition to MVA-BN/FPV-Brachyury or other agents used in trial. History
of allergic reactions to aminoglycoside antibiotic or egg products.

- Serious or uncontrolled intercurrent illness, included but not limited to, ongoing or
active infection, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia or psychiatric illness/social situations that, in the opinion of
the investigator, would limit compliance with trial requirements.

- Pregnant women are excluded from this trial due to the unknown effects of the
BN-Brachyury on the fetus or infant.

- HIV-positive patients are ineligible because of the potential for decreased immune
response to the vaccine.

- Significant cardiovascular disease, which includes but is not limited to New York
Heart Association Heart Failure Class II or greater, myocardial infarction within the
previous 3 months, unstable arrhythmias, unstable angina.
We found this trial at
4
sites
55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Gregory Cote, MD
Phone: 617-643-2427
Massachusetts General Hospital Cancer Center An integral part of one of the world
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Steven Attia, D.O
Phone: 904-953-3972
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Phoenix, Arizona 85054
Principal Investigator: Mahesh Seetharam, MD
Phone: 480-342-3741
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Phoenix, AZ
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Rochester, Minnesota 55905
Principal Investigator: Scott H Okuno, MD
Phone: 507-286-5027
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Rochester, MN
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