A Phase 2 Study of GI-6207 in Patients With Recurrent Medullary Thyroid Cancer
Medullary Thyroid Cancer
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
Medullary thyroid cancer, thyroid cancer
Study Type
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: GI-6207
Type: Biological
Overall Status
This study is being done because standard therapies have not been effective in medullary thyroid cancer (MTC). The NIH research team is studying how an experimental vaccine will affect MTC. The vaccine (GI-6207) is made with yeast and designed to target cells making a protein called CEA (carcinoembryonic antigen). The study is testing the safety and tolerability of GI-6207. GI-6207 is made with baker's yeast (Saccharomyces cerevisiae). The yeast is genetically modified, made to express CEA, then heat killed. The goal is to get the immune system to respond to the vaccine by making immune cells that can recognize and attach tumor cells. Patients will be randomized to GI-6207 or to surveillance for 6 months followed by treatment with GI-6207. Patients will receive up to 2 years of treatment.
Detailed Description
Medullary thyroid cancers are CEA (carcinoembryonic antigen) expressing tumors. Indolent disease course may allow necessary time to generate an immune response. There are no standard treatments for patient with asymptomatic metastatic disease. GI-6207 can induce specific T cell responses against the CEA antigen. Previous data suggests that therapeutic cancer vaccines can alter tumor growth rates and do so within 6 months. An analysis of medullary thyroid cancer patients suggest that 6 months of surveillance is adequate to calculate a growth rate in the control arm. A comparison of growth rates after 6 months will be made between patients treated with GI-6207 and those on surveillance. For patients on surveillance, they will also be compared to their own baseline growth rate after they have received 6 months of therapy. Once patients have completed 1 year of therapy, patients without radiographic progression will have the option to receive GI-6207 every 3 months for an additional 12 months.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with evidence of metastatic medullary thyroid cancer including disease that is evaluable on bone or CT scan.

- Patients with minimal or no disease related-symptoms

- ECOG (Eastern Cooperative Oncology Group) 0-1

Exclusion Criteria:

- Previous chemotherapy

- Previous vandetanib

- Autoimmune diseases; evidence of being immunocompromised; serious inter-current medical illness; cardiac disease; prior splenectomy (history of previous thyroid autoimmune disease will be allowed as these patients will have had total thyroidectomy)

- Brain metastasis, history of seizures, encephalitis, multiple sclerosis

- Serious hypersensitivity reaction to yeast-based products

- Pericardial-based masses greater than 1 cm or thoracic lesions larger than 2cm
National Institutes of Health Research Facility
Bethesda, Maryland, United States
Status: Recruiting
Contact: Myrna Rauckhorst, RN - 301-496-7224 - mrauckhorst@mail.nih.gov
Start Date
February 2013
Completion Date
December 2017
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page