An Open Label Phase I Study to Eval the Safety and Tolerability of a Vaccine (GI-6207) Consisting of Whole, Heat-killed Recombinant Saccharomyces Cerevisiae (Yeast) Genetically Modified to Express CEA Protein in Adults With Metastatic CEA-expressing ...
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|ClinicalTrials.gov Identifier: NCT00924092|
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : December 12, 2019
- To find out the maximum tolerated dose of the GI-6207 vaccine (the highest dose that does not cause unacceptable side effects), and to evaluate any side effects.
- To see if GI-6207 has any effect on patients tumors.
- To learn how the vaccine causes immune responses against the cancer.
- Patients 18 years of age and older who have been diagnosed with a cancer that has not responded to standard treatments. Patients must not be allergic to yeast or yeast products.
- Initial physical examination, blood and tissue sampling, computed tomography (CT) scan, and skin test to determine eligibility for the procedure.
- Treatment with GI-6027 in seven 14-day cycles as follows:
- Vaccine administered on days 1, 15, 29, 43, 57, 71, and 85.
- Vaccine given at four sites around the body: right and left chest area below the armpit, and right and left upper thigh in the pelvic region. (These areas drain into parts of your body that contain large numbers of lymph nodes. The lymph nodes contain immune cells that may be activated by the vaccine to target cancer cells.)
- Clinic visits for physical examinations to check vital signs, take additional blood and urine samples, and perform other tests needed for the study.
- After day 85 (about 3 months), patients will continue to receive vaccine monthly (or every 28 days) as long as the vaccine is not producing harmful effects or side effects and the cancer is either stable or reducing. Patients who do well on the vaccine may continue to receive it for as long as it is available.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Breast Cancer Lung Cancer Colorectal Cancer Head and Neck Cancer||Biological: GI-6207 [Recombinant Saccharomyces Cerevisia Drug: (Yeast CEA Vaccine)(GI-6207[Recombinant Sarrcharomyces Cerevusua-CEA (610D)])||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Phase I Study to Evaluate the Safety and Tolerability of Vaccine (GI-6207) Consisting of Whole, Heat-Killed Recombinant Saccharomyces Cerevisiae Genetically Modified to Express CEA Protein in Adults With Metastatic CEA-Expressing Carcinoma|
|Study Start Date :||March 13, 2009|
|Actual Study Completion Date :||August 2, 2012|
- To determine the safety and tolerability of escalating doses of a heated-killed yeast-based vaccine that targets tumors that express CEA.
- To evaluate CD4 and CD8 immunologic response. To evaluate humoral immune response to yeast antigen. To evaluate evidence of clinical benefit such as PFS, OR, & decreases in circulating tumor cells & tumor markers.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924092
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Ravi A Madan, M.D.||National Cancer Institute (NCI)|