Clinical Trials Logo
  1. Home
  2. Primary Peritoneal Carcinoma
  3. NCT02033616

Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Advanced Epithelial Ovarian Carcinomas

Primary Peritoneal Carcinoma Clinical Trial

Official title:
Phase II, Double-Blind, Randomized Trial Of AVOVA-1 (Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens) Vs. Autologous Peripheral Blood Mononuclear Cells (MC) In Patients With Stage III Or IV Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma After Primary Therapy

Clinical Trial Summary

This is a double-blind study in which approximately 99 study patients will be randomized in a 2:1 ratio to receive either AVOVA-1 or MC. Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient PMBC were obtained, and (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%). The primary endpoint of this trial is death from any cause with the metric of OS from the date of randomization. PFS will be a secondary endpoint and will be calculated as the time from the date of randomization for treatment until subjective tumor progression or death. Progression will be subjectively defined by the treating physician, and is expected to be based on tumor marker levels (e.g. CA-125) and/or imaging. Secondarily, we will also define PFS and OS from the date of debulking surgery. Patients will be stratified into (1) no evidence of disease (NED) (no measurable or non-measurable disease per RECIST and normal CA-125 levels) or (2) non-NED (measurable or non-measurable disease per RECIST or elevated CA-125 levels).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02033616
Study type Interventional
Source Aivita Biomedical, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 18, 2017
Completion date March 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT01442051 - Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer N/A
Active, not recruiting NCT03648489 - Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma) Phase 2
Completed NCT01031381 - Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer Phase 2
Terminated NCT01202890 - Study of Revlimid With Doxil and Avastin for Patients With Platinum Resistant Ovarian Cancer Phase 1
Completed NCT00561795 - Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors Phase 2
Completed NCT00301756 - Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors Phase 2
Completed NCT00066456 - Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer Phase 1
Completed NCT00045682 - CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Phase 2
Withdrawn NCT04368130 - SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care N/A
Terminated NCT04814875 - A Study to Evaluate the Combination of ATX-101 and Platinum-based Chemotherapy Phase 1/Phase 2
Completed NCT00989651 - Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Recruiting NCT05537844 - Longitudinal Sample Collection to Investigate Adaptation and Evolution of Ovarian High-grade Serous Carcinoma
Terminated NCT03585764 - MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Completed NCT03921658 - The Role of Cytomegalovirus and Inflammation on Patient Symptoms and Outcomes in Ovarian Cancer
Completed NCT04088786 - Phase I Trial HIPEC With Nal-irinotecan Phase 1
Withdrawn NCT00551265 - Oregovomab With or Without Cyclophosphamide in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Responded to Second-Line Chemotherapy N/A
Completed NCT00093626 - Sorafenib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer Phase 2
Completed NCT03367260 - The Treatment Preferences of Women Diagnosed With Ovarian Cancer
Recruiting NCT03983226 - Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial) Phase 2
Recruiting NCT03373058 - Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery Phase 3