Clinical Trial: Autologous Dendritic Cell-Tumor Cell Immunotherapy for Advanced Epithelial Ovarian Carcinomas

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Phase II, Double-Blind, Randomized, Single Center Trial Of Ovapuldencel-T (Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells In GM-CSF) vs. Autologous Peripheral Blood Mononucle

Brief Summary:

This is a double-blind study in which approximately 99 study patients will be randomized in a 2:1 ratio to receive either ovapuldencel-T (autologous dendritic cells loaded with irradiated autologous tumor cells in GM-CSF) or MC (autologous PBMC in GM-CSF). Patients eligible for treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis, (4) are scheduled for primary adjuvant chemotherapy, and (5) have an ECOG performance grade of 0 or 1.

The primary endpoint of this trial is death from any cause with the metric of overall survival (OS) from the date of randomization. Progression-free survival (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) platinum-resistant, based on progression during adjuvant chemotherapy or detectable disease at the conclusion of adjuvant therapy or (2) platinum-sensitive, with no evidence of disease (NED) at the conclusion of adjuvant therapy (per elevated blood CA-125 and/or tumor markers and/or detection of disease by physical examination or imaging).

Summary of Stratification and Treatment Plan Platinum Sensitive Platinum Resistant Ovapuldencel-T Arm Ovapuldencel-T + Paclitaxel Ovapuldencel-T+ Secondary Adjuvant therapy MC Arm Mononuclear cells + Paclitaxel Mononuclear cells + Secondary Adjuvant therapy


Detailed Summary:

Sponsor: NeoStem, Inc.

Protocol Title: Phase II, Double-Blind, Randomized, Single Center Trial Of Ovapuldencel-T (Autologous Dendritic Cells Loaded With Irradiated Autologous Tumor Cells In GM-CSF) vs. Autologous Peripheral Blood Mononuclear Cells In GM-CSF (MC) as a Component of Maintenance or Secondary Therapy in Patients with Stage III or IV Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma after Debulking Surgery and Adjuvant Chemotherapy

Study Design: A double-blind, randomized, single center trial.

Number of Study Centers: 1.

Study Phase: Phase II.

Objectives:

Primary Objective:

• Compare overall survival (OS) from the date of randomization for patients treated with ovapuldencel-T (autologous dendritic cells pulsed with autologous irradiated tumor cells in GM-CSF) to patients treated with autologous blood mononuclear cells in GM-CSF (MC) control.

Secondary Objectives:

  • Establish safety of repeated administration of ovapuldencel-T.
  • Compare duration of progression-free survival (PFS) from the date of randomization for patients treated with ovapuldencel-T to patients treated with MC.
  • In the subset of platinum-sensitive patients with no evidence of disease (NED) after post-debulking chemotherapy, compare OS and PFS from date of randomization
  • In the subset of platinum-resistant patients, compare OS and PFS from date of ran
    Sponsor: Caladrius Biosciences, Inc.

    Current Primary Outcome: Primary Efficacy Endpoint: Overall Survival [ Time Frame: 5 years ]

    Overall Survival: time to death from date of randomization


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Secondary Efficacy Endpoints: Success rate for establishing a tumor cell line [ Time Frame: 5 years ]
      Secondary Efficacy Endpoints: The success rate for establishing patient tumor cell lines
    • Secondary Efficacy Endpoint: Progression Free Survival (PFS) [ Time Frame: 5 years ]
      Progression Free Survival: time to disease progression or death from date of randomization
    • Secondary Efficacy Endpoint: OS and PFS for platinum-sensitive patients [ Time Frame: 5 years ]
      Secondary Efficacy Endpoint: OS and PFS for the subset of patients who are platinum-sensitive and have no evidence of disease (NED) after adjuvant therapy
    • Secondary Efficacy Endpoint: OS and PFS for platinum-resistant patients [ Time Frame: 5 years ]
      Secondary Efficacy Endpoint: OS and PFS for the subset of patients who are platinum-resistant after/during primary adjuvant chemotherapy
    • Secondary Efficacy Endpoints: OS and PFS from date of debulking surgery and diagnosis [ Time Frame: 5 years ]
      Secondary Efficacy Endpoints: OS and PFS from date of debulking surgery and date of diagnosis


    Original Secondary Outcome: Same as current

    Information By: Caladrius Biosciences, Inc.

    Dates:
    Date Received: January 7, 2014
    Date Started: July 2016
    Date Completion: December 2022
    Last Updated: April 25, 2016
    Last Verified: September 2015