NCT00924092 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Hodge JW, Tsang KY, Poole DJ, Schlom J
General keynote: vaccine strategies for the therapy of ovarian cancer. Gynecol Oncol. 2003 Jan;88(1 Pt 2):S97-104; discussion S110-3. Review.
Kass ES, Greiner JW, Kantor JA, Tsang KY, Guadagni F, Chen Z, Clark B, De Pascalis R, Schlom J, Van Waes C
Carcinoembryonic antigen as a target for specific antitumor immunotherapy of head and neck cancer. Cancer Res. 2002 Sep 1;62(17):5049-57.
Robbins PF, Eggensperger D, Qi CF, Schlom J
Definition of the expression of the human carcinoembryonic antigen and non-specific cross-reacting antigen in human breast and lung carcinomas. Int J Cancer. 1993 Apr 1;53(6):892-7.

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

Details for clinical trial NCT00924092

Clinical trial NCT00924092 - References