Spots Global Cancer Trial Database for Dendritic Cell Vaccine for High Risk Ovarian Cancer Patients

Study Description

Brief Summary: This is a randomized Phase I/II study designed to assess the induction of an anti-tumor immune response; the effect of cyclophosphamide on the vaccine; and to assess safety in subjects with advanced ovarian cancer or primary serous peritoneal cancer given a multivalent DC vaccine, with or without a single dose of cyclophosphamide. Potential benefit may range from no direct benefit to the study participants to stimulation of the subject's own immune system to attack ovarian cancer to prevent relapse.

Detailed Description: HLA-A2+ subjects with stage II-IV who have completed chemotherapy and are in clinical remission or patients with stage I-IV advanced ovarian cancer or primary serous peritoneal cancer in clinical remission post treatment for disease recurrence occurring after a progression-free interval of at least two years will be eligible. Patients will be evaluated by standard imaging techniques. Patients will be randomized to cyclophosphamide 300 mg/m2 (arm 2) or no cyclophosphamide (arm 1). All subjects will receive intradermal injections of DC on day 2 and on week 3, 6, and 9 (+ 3 days). All subjects will undergo leukocyte apheresis at study enrollment and at week 10, which is the end of active study intervention. All study arm 1 and 2 patients (without prior vaccination with the current season's vaccine) will receive a single dose of trivalent killed influenza vaccine, and a single dose of Prevnar pneumococcal vaccine on the day they receive their first intradermal injections of DC on day 2.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial