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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-C-0095

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

Calcitonin;
T-cells;
Immune Response;
HLA Patients;
Vaccine

Recruitment Keyword(s)

None

Condition(s)

Medullary Thyroid Cancer (MTC)

Investigational Drug(s)

GI-6207

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: GI-6207 [Recombinant Saccharomyces cerevisiae-CEA (610D)]

Supporting Site

National Cancer Institute

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.

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Eligibility

INCLUSION CRITERIA:

Participants must meet the following criteria for participation:

- Diagnosis: Patients must have histologically confirmed medullary thyroid cancer by the Laboratory of Pathology or a pathology report and history consistent with medullary thyroid cancer. It is not uncommon for a secondary, minor pathologic focus of another form of thyroid cancer to be coincidentally found in 15-20% of patients with medullary thyroid cancer. In such cases, eligibility is based on the discretion of the investigator.

- Patients must have evidence of metastatic medullary thyroid cancer including disease that is evaluable on bone, CT scan or MRI. (Patients who are surgical candidates and potentially rendered disease free with surgical resection are not eligible.)

- Patients must have elevated calcitonin levels, greater than 8 pg/mL in females and 16 pg/mL in males

- 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 scheduled narcotics.)

- No brain metastasis, history of seizures, encephalitis, or multiple sclerosis.

- Age greater than or equal to 18 years

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

- No systemic steroid use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent IV contrast, allergic reaction or anaphylaxis (in patients who have known contrast allergies) are allowed.

- Hematological eligibility parameters

-- Granulocyte count greater than or equal to 1,500/mm^3

-- Platelet count greater than or equal to 100,000/mm^3

-- Hemoglobin greater than or equal to 9 g/dL

- Biochemical eligibility parameters (within 16 days of starting therapy)

--Baseline renal function:

--- Serum creatinine less than or equal to 1.5 x upper limit of normal OR creatinine clearance on a 24-h urine collection of greater than or equal to 60 mL/min.

-- Hepatic function:

--- Bilirubin less than or equal to 1.5 mg/dl, in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0 mg/dL

--- AST and ALT< 2.5 times upper limit of normal

- No other active malignancies within the past 3 years (with the exception of nonmelanoma skin cancers, prostate cancer patients with stable biochemical recurrence/not on systemic therapy or carcinoma in situ of the bladder).

- Willing to travel to the NIH for follow-up visits

- Able to understand and sign informed consent.

- Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 6 months after the last vaccination therapy.

EXCLUSION CRITERIA:

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.

--1 Human immunodeficiency virus (HIV) positivity due to the potential for decreased immune response to the vaccine.

-- Active autoimmune diseases requiring treatment or a recent history of autoimmune disease requiring therapy, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis. This requirement is due to the potential risks of exacerbating autoimmunity. However, patients with vitiligo may be enrolled. (Patients with history of autoimmune thyroid conditions will be allowed as these patients will be on replacement medications.)

-- Concurrent use of systemic steroids, except for physiologic doses of systemic steroid replacement or local (topical, nasal, eye drops 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.

- Pregnant or breast-feeding women, due to the unknown effects of GI-6207 on the fetus or infant.

- Serious inter-current medical illness which would interfere with the ability of the patient to carry out the treatment program.

- Untreated brain metastases (or local treatment of brain metastases within the last 6 months) due to the poor prognosis of these patients and difficulty ascertaining the cause of neurologic toxicities.

- Patients with pericardial masses >1 cm or thoracic lesions larger than 2 cm will be excluded.

- Concurrent chemotherapy.

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

- Participation in another interventional clinical trial at the time of enrollment.

- 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.

- Patients with second malignancy within 3 years of enrollment; patients treated surgically with a curative intent, such as non-melanoma skin cancers, localized kidney cancer or carcinoma in situ of the bladder, are not excluded. Patients with MEN2 and a history of pheochromocytoma will also not be excluded. In addition patients with prostate cancer who do not require systemic therapy will not be excluded. (A secondary, minor pathologic focus of another form of thyroid cancer may be coincidentally found in 15-20% of patients with medullary thyroid cancer. In such cases, eligibility is based on the discretion of the investigator.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Ravi A. Madan, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 13N240B
10 CENTER DR
BETHESDA MD 20892
(301) 480-7168
rm480i@nih.gov

Corrine M. Keen, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D44B
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6097
ck232s@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01856920

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