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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 100

Referral Letter Required


Population Exclusion(s)


Special Instructions

Currently Not Provided


Vaccine Therapy;
Dose-Limiting Toxicity;
Maximum Tolerated Dose;
Clinical Response;
Immune Response

Recruitment Keyword(s)

Solid Tumor


Malignant Solid Tumors;
Colon Neoplasms

Investigational Drug(s)

GI-6301 Vaccine (Yeast-Brachyury)

Investigational Device(s)



Other: GU-6301 (Yeast Brachyury Vaccine)

Supporting Site

National Cancer Institute


- Cancer vaccines are being developed to help teach the body's immune system to attack and destroy cancer cells. A new vaccine being tested targets Brachyury protein. This protein is present in some tumor cells, and it can help tumor cells spread to other parts of the body. Researchers want to see whether the new Brachyury protein vaccine can help treat people with advanced carcinomas.


- To test the safety and effectiveness of a cancer vaccine that targets Brachyury protein in tumor cells.


- Individuals at least 18 years of age who have advanced cancers that have not responded or are no longer responding to standard treatments.

- Because the vaccine is made with yeast, people with yeast allergies will not be eligible.


- Participants will be screened with a medical history and physical exam. Imaging studies will be used to examine the cancer. Heart and thyroid function tests will be conducted. Blood and urine samples will also be collected.

- Participants will receive vaccine injections every 2 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.

- Treatment will be monitored with frequent blood tests and imaging studies. Other tests will be given as directed by the study doctors. 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.

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Participants must meet the following criteria for participation:

-Diagnosis: Patients must have histologically confirmed malignancy by the Laboratory of Pathology, NCI, that is metastatic or unresectable locally advanced malignant solid tumor. In the case of Chordoma, unresectable, locally recurrent, or metastatic tumors are acceptable for enrollment, given that this represents incurable disease. Efforts will be made, as much as possible, to enroll patients with tumor types with known increased expression of Brachyury (such as lung, breast, ovarian, prostate, colorectal, pancreatic, or chordoma).

- Patients may have disease that is measurable or non-measurable but evaluable disease

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study entry (Karnofsky greater than or equal to 70)

- Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of Yeast Brachyury vaccine in patients < 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.

- Prior Therapy: Completed or had disease progression on at least one prior line of diseaseappropriate therapy for metastatic disease, or not be a candidate for therapy of proven efficacy for their disease.

- Patients must have normal organ and marrow function as defined below:

-- Serum creatinine 1.5 times upper limit of normal OR creatinine clearance on a 24-h urine collection of 60 mL/min.

-- ALT and AST 2.5 times the upper limits of normal.

-- Total bilirubin less than or equal to 1.5 times upper limit of normal OR in patients with Gilbert?s syndrome, a total bilirubin 3.0.

-- Hematological eligibility parameters (within16 days of starting therapy):

--Granulocyte count 1,500/mm(3)

--Platelet count 100,000/m(3)

-- Patients must have baseline pulse oximetry > 90% on room air.

- Recovered completely (Grade 1 or baseline) from any reversible toxicity associated with recent therapy. Typically this is 3 4 weeks for patients who most recently received cytotoxic therapy, except for the nitrosoureas and mitomycin C for which 6 weeks is needed for recovery.

- There should be a minimum of 2 weeks from any prior chemotherapy, immunotherapy and/or radiation.

- Prior immune therapy is allowed.

- Men and women of child-bearing potential must agree to use effective birth control or abstinence during and for a period of 4 months after the last vaccination therapy.

- Patients with prostate cancer must continue to receive GnRH agonist therapy (unless orchiectomy has been done). If a patient has refused GnRH therapy, they may be enrolled on a dose level for which the safety has already been determined.

- Patients with ER+ breast cancer being treated with adjuvant hormonal therapy (selective estrogen receptor modulator or aromatase inhibitor) who have rising tumor markers as evidence of disease progression or metastatic disease on scans may continue on hormonal therapy while being treated with vaccine.

- Patients must be negative for yeast allergy skin test

- Ability to understand and the willingness to sign a written informed consent document.


Patients with any of the following will not be eligible for participation in this study:

- Patients should have no evidence of immune dysfunction as listed below.

-- Human immunodeficiency virus (HIV) positivity due to the potential for decreased immune response to the vaccine.

-- Active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. This requirement is due to the potential risks of exacerbating autoimmunity. However, patients with vitiligo, diabetes mellitus, and hashimoto s thyroiditis on appropriate replacement therapy may be


--Concurrent use of systemic steroids, except for physiologic doses of systemic steroid replacement or local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (e.g., in patients with exacerbations of reactive airway disease or to prevent IV contrast allergic reaction or anaphylaxis in patients who have known contrast allergies) are allowed.

- History of allergy or untoward reaction to yeast-based products (any hypersensitivity to yeast-based products will be excluded).

- Pregnant or breast-feeding women, due to the unknown effects of the Yeast Brachyury vaccine on the fetus or infant.

- Serious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis.

-Untreated brain metastases (or local treatment of brain metastases within the last 6 months) and or spinal cord metastasis.

- Patients with pericardial masses > 1 cm will be excluded.

- Concurrent chemotherapy. (However, the following anti-tumor therapies will be allowed: Trastuzumab for HER2+ breast cancer and hormonal therapy for breast (e.g., selective estrogen receptor modulators, aromatase inhibitors) and prostate cancer (e.g., GnRH antagonists/agonists or antagonists and androgen receptor antagonists).

- Chronic hepatitis infection, including B and C, because potential immune impairment caused by these disorders may diminish the effectiveness of this immunologic therapy.

- Patients requiring continuous tricyclic antidepressant therapy should be excluded due to the interference with the yeast skin test in creating false negative test results.

- Participation in another interventional clinical trial within 28 days before start of study treatment.

- Any significant disease that, in the opinion of the investigator, may impair the patient s tolerance of study treatment.

- Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

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Baranova AV, Lobashev AV, Ivanov DV, Krukovskaya LL, Yankovsky NK, Kozlov AP. In silico screening for tumour-specific expressed sequences in human genome. FEBS Lett. 2001 Nov 9;508(1):143-8.

Krukovskaja LL, Baranova A, Tyezelova T, Polev D, Kozlov AP. Experimental study of human expressed sequences newly identified in silico as tumor specific. Tumour Biol. 2005 Jan-Feb;26(1):17-24. Epub 2005 Feb 28.

Palena C, Polev DE, Tsang KY, Fernando RI, Litzinger M, Krukovskaya LL, Baranova AV, Kozlov AP, Schlom J. The human T-box mesodermal transcription factor Brachyury is a candidate target for T-cell-mediated cancer immunotherapy. Clin Cancer Res. 2007 Apr 15;13(8):2471-8.

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Principal Investigator

Referral Contact

For more information:

James L. Gulley, M.D.
National Cancer Institute (NCI)
BG 10 RM 12N226
(301) 435-2956

Myrna Rauckhorst, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 13N210
10 Center Drive
Bethesda, Maryland 20892
(301) 496-7224

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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