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Solid Tumor

An Open Label Phase I Study to Evaluate the Safety and Tolerability of GI-6301 Vaccine Consisting of Whole, Heat-killed Recombinant Saccharomyces Cerevisiae (Yeast) Genetically Modified to Express Brachyury Protein in Adults With Solid Tumors

NCI-12-C-0056, NCT01519817

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James L. Gulley, M.D., Ph.D., F.A.C.P.
Senior Investigator
Phone: 301-435-2956

Referral Contact(s):

Laura D. Otten, R.N., B.S.N., O.C.N.
Medical Oncology Referral Coordinator
Phone: 301-451-1228
1-866-611-6310 (Toll Free)
Fax: 301-480-0919

Myrna Rauckhorst, R.N.
Research Nurse Specialist
Phone: 301-496-7224
Fax: 301-480-1779


Key Eligibility Criteria:

  • Histologically or cytologically proven metastatic or unresectable locally advanced solid tumor (tumor types with known increased expression of Brachyury such as lung, breast, ovarian, prostate, colorectal, or pancreatic)
  • Completed or had disease progression on at least one prior line of disease appropriate therapy for metastatic disease or not be a candidate for therapy of proven efficacy for their disease
  • ≥ 18 years of age
  • Measurable or non-measurable but evaluable disease
  • Adequate organ function as defined by liver, kidney, and hematologic laboratory testing
  • No acquired immune defects, systemic autoimmune disease, history of organ transplant, or history of active inflammatory bowel disease
  • Patients with prostate cancer must continue to receive GnRH agonist therapy (unless orchiectomy has been done)
  • No history of allergy or untoward reaction to yeast-based products
  • No concurrent chemotherapy and/or Trastuzumab

Study Outline:

  • Screening with physical examination, blood samples and imaging studies to determine eligibility for the study
  • Vaccine injections every two weeks, for a total of seven visits
  • After seven visits, if the cancer has shrunk or stopped growing, participants will continue to have the vaccine about once a month
  • Participants will be monitored with frequent blood tests and imaging studies
  • Some participants will have apheresis to collect additional blood cells for study
  • Participants will continue to receive the vaccine as long the tumor does not start growing again and there are no serious side effects

Additional Information:

  • This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
  • There is no charge for medical care received at NIH Clinical Center.

Reviewed: 9/6/12
Updated: 2/1/12

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