BN Brachyury and Radiation in Chordoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2022-01-25

Brief Summary

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The 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 is needed to proceed to stage 2.

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Detailed Description

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Conditions

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Chordoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BN-Brachyury plus radiation

BN-Brachyury as both MVA and FPV are given before radiation, and followed by FPV-Brachyury

Group Type EXPERIMENTAL

BN-Brachyury plus radiation

Intervention Type BIOLOGICAL

MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.

Interventions

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BN-Brachyury plus radiation

MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No