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A Phase 2 Study of GI-6207 in Patients With Recurrent Medullary Thyroid Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Medullary Thyroid Cancer

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Trial Information

A Phase 2 Study of GI-6207 in Patients With Recurrent Medullary Thyroid Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Calcitonin growth rate kinetics after 6 months of therapy in patients with MTC

Outcome Time Frame:

after 6 months of therapy

Safety Issue:

No

Principal Investigator

Ravi A Madan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Food and Drug Administration

Study ID:

GI-6207-02

NCT ID:

NCT01856920

Start Date:

February 2013

Completion Date:

December 2015

Related Keywords:

  • Medullary Thyroid Cancer
  • Medullary thyroid cancer
  • thyroid cancer
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location
National Institutes of Health Research Facility Bethesda, Maryland  20892