Autologous OC-DC Vaccine in Ovarian Cancer

Early Phase 1

Completed

• Conditions: Chemotherapy; Tumor; Ovarian Cancer

• Registration Number: NCT01132014
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

This is a Five cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide or in combination with intravenous Bevacizumab, cyclophosphamide and aspirin. Study duration is 24 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-27
• Status Verified: 2018-04
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Last Update Submitted: 2018-06-08
• Last Update Posted: 2018-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety	30 days of last vaccination	Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version3.0). All toxicities observed within 30 days of last vaccination will be included.

Secondary Outcome Measures

Name	Time	Method
Dose limiting toxicity		Dose-limiting toxicity is defined as: any Grade 3 or higher allergic, autoimmune or injection site reaction or any Grade 4 hematologic or non-hematologic toxicity (except fever).
Clinical Response		Clinical Response will be determined by RECIST criteria. Response rate is the proportion of patients that achieve CR or PR.
Immune Response Immune Response		Immune response will be evaluated by IFN-g ELISPOT analysis of tumor-reactive T cells, and in HLAA2+ subjects, by tetramer analysis of Her-2 specific T cells in peripheral blood. Response is defined by a 3 fold increase relative to pre-vaccination.

Trial Locations

Locations (1)

Ovarian Cancer Research Center; 🇺🇸 Philadelphia, Pennsylvania, United States