Status:
COMPLETED
A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant With Ovarian, Tubal or Peritoneal Cancer
Lead Sponsor:
Michael Morse, MD
Collaborating Sponsors:
Immunotope
Conditions:
Epithelial Ovarian, Tubal or Peritoneal Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety of administering a peptide vaccine consisting of twelve different tumor-rejection antigens known to be present on ovarian tumor cells. The vaccine is designed to el...
Detailed Description
The primary endpoint will be to determine the safety and feasibility of administering ovarian cancer peptides to women who have undergone debulking surgery and systemic chemotherapy, with the secondar...
Eligibility Criteria
Inclusion
- Must be HLA-A2+ patients with histologically confirmed, stage III-IV epithelial ovarian, tubal, or peritoneal cancer who have undergone optimal debulking and had a complete clinical response to front-line platin/taxane based chemotherapy.
- Subjects must have received front-line platin compound and taxane chemotherapy following primary surgical resection. Front-line treatment can include up to 12 cycles of treatment.Subjects must receive the first dose of study medication at least 4 weeks and up to 6 months since completing their last dose of front-line chemotherapy.A complete clinical response defined as: no evidence of disease on physical exam,CT imaging scans of the abdomen and pelvis, chest x-ray and a CA-125 below the upper limit of normal.
Exclusion
- History of autoimmune disease, serious intercurrent chronic or acute illness, active hepatitis, serologic evidence for HIV, splenectomy, or be receiving steroid or immunosuppressive therapy.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00437502
Start Date
March 1 2007
End Date
January 1 2010
Last Update
November 19 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710