Medullary Thyroid Cancer (MTC) Clinical Trial
Official title:
A Phase 2 Study of GI-6207 in Patients With Recurrent Medullary Thyroid Cancer
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.
BACKGROUND:
- CEA is overexpressed in multiple malignancies, including medullary thyroid cancer where
CEA is universally expressed on tumor cells.
- There is no standard treatment for patients with asymptomatic or minimally symptomatic,
metastatic medullary thyroid cancer. The only effective FDA-approved therapy
(vandetanib) comes with significant toxicity, so it is not used until patients have
symptomatic or rapidly progressing disease.
- Preclinical studies have shown that GI-6207 can induce a strong immune response to CEA
as well as therapeutic anti-tumor responses.
- A previous Phase I GI-6207 study has demonstrated safety and enhanced immune response in
some patients.
- Preliminary data suggests that tumor growth rates can be calculated in medullary thyroid
cancer patients within 3 months
- Retrospective data from prostate cancer studies suggest that vaccines can alter tumor
growth rates within 3-4 months
OBJECTIVES:
Primary:
-To determine the effect of GI-6207 on calcitonin growth rate kinetics after 6 months of
therapy in patients with medullary thyroid cancer
ELIGIBILITY:
- Patients will have evidence of metastatic medullary thyroid cancer including disease
that is evaluable on bone or CT scan.
- Patients with minimal or no disease related-symptoms (minimal symptoms will include
those that do not affect activities of daily living or pain that does not require
regularly schedule narcotics.)
- ECOG 0-1
- No previous chemotherapy
- No previous vandetanib
- Should have no autoimmune diseases; no evidence of being immunocompromised; no serious
inter-current medical illness; no cardiac disease; no prior splenectomy. (History of
previous thyroid autoimmune disease will be allowed as these patients will have had
total thyroidectomy.)
- No brain metastasis, history of seizures, encephalitis, or multiple sclerosis
- No pericardial-based masses greater than 1 cm or thoracic lesions larger than 2 cm
Design:
- Randomized, phase 2 study to determine the effect of GI-6207 on calcitonin growth rate
after 6 months of GI-6207
- Patients will be randomized to either initial GI-6207 therapy or 6 months of
surveillance followed by GI-6207 therapy.
- GI-6207 will be administered subcutaneously at 4 sites at dose of 10 yeast units per
site, biweekly for 7 visits (day 1, 15, 29, 43, 57, 71, 85), then monthly up to 1 year
of treatment. (For patients randomized to surveillance and then GI-6207, they will get a
full year of GI-6207 after a 6 month surveillance period.)
- Once patients have completed one year of therapy with GI-6207, patients without
radiographic progression will have the option to receive vaccine every 3 months for an
additional 12 months. Patients who remain on vaccine will continue to be scanned every 3
months.
- Immune monitoring via apheresis will be done prior to enrollment and at 6 months for all
appropriate and consenting patients. Patients who are evaluable for immunologic response
by the ELISPOT Assay (HLA 02, 03 and 24) will have apheresis at start of GI-6207 therapy
and then every 3 months while on GI-6207 treatment when feasible.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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