Epithelial Ovarian, Tubal or Peritoneal Cancer Clinical Trial
Official title:
A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA-51) as Consolidation Following Optimal Debulking and Systemic Chemotherapy for Women With Advanced Stage Ovarian, Tubal, or Peritoneal Cancer
Verified date | November 2012 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 elicit immune responses against twelve different pathways that are essential to tumor growth, survival and metastasis.HLA-A2+ is a required criteria for subject eligibility.
Status | Completed |
Enrollment | 8 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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 Criteria: - History of autoimmune disease, serious intercurrent chronic or acute illness, active hepatitis, serologic evidence for HIV, splenectomy, or be receiving steroid or immunosuppressive therapy. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Michael Morse, MD | Immunotope |
United States,
Morse MA, Secord AA, Blackwell K, Hobeika AC, Sinnathamby G, Osada T, Hafner J, Philip M, Clay TM, Lyerly HK, Philip R. MHC class I-presented tumor antigens identified in ovarian cancer by immunoproteomic analysis are targets for T-cell responses against — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Date of first objective finding will be used to define the date of relapse | From date of enrollment to date of confirmed relaspe | Yes |