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Cancer Vaccine

A for Medullary Thyroid Cancer

Phase 2
Waitlist Available
Research Sponsored by NantCell, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after treatment
Awards & highlights

Study Summary

Background: - GI-6207 is an experimental cancer vaccine made with baker's yeast. The yeast has been modified to help the immune system target a protein called CEA. CEA is found on the surface of some kinds of tumor cells, including thyroid cancer cells. Researchers want to see if GI-6207 can encourage the body's immune system to attack and kill tumor cells that contain the CEA protein. They will test to see whether this vaccine is a safe and effective treatment for medullary thyroid cancer that has not responded to earlier treatments. Objectives: - To test the safety and effectiveness of the GI-6207 vaccine for advanced medullary thyroid cancer. Eligibility: - Individuals at least 18 years of age who have medullary thyroid cancer that has not responded to earlier treatments. Design: Participants will be screened with a physical exam and medical history. They will provide blood and tumor samples and have an imaging study of the neck and chest. They will also have a skin test to make sure that they are not allergic to the yeast in the vaccine. Participants will be divided into two groups. One group will start to take GI-6207 immediately for 1 year. The second group will have 6 months of monitoring and tests with no vaccine, and then will take GI-6207 for 1 year. GI-6207 will be given every other week for the first seven visits (about 3 months), and then monthly for the remaining year of treatment. It will be given as injections beneath the arm and in the upper thigh. These locations will help the vaccine enter the lymph nodes and reach the immune system more quickly. Participants will be monitored with frequent blood and urine tests and imaging studies. Participants will have regular follow-up visits after their year of study vaccines.

Eligible Conditions
  • Medullary Thyroid Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Calcitonin growth rate kinetics after 6 months of therapy in patients with MTC
Secondary outcome measures
CEA-specific T-cells at 3 months compared to baseline
Time to progression

Trial Design

2Treatment groups
Experimental Treatment
Group I: BExperimental Treatment1 Intervention
6 months of surveillance followed by GI-6207 for 1 year
Group II: AExperimental Treatment1 Intervention
GI-6207 for 1 year

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,928,484 Total Patients Enrolled
NantCell, Inc.Lead Sponsor
14 Previous Clinical Trials
1,823 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~3 spots leftby May 2025