Clinical Trial: Nonrandomized, Open-Label Phase IIb Efficacy Trial of Cancer Macrobeads Compared With Best Supportive Care in Patients With Treatment-Resistant Colorectal Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase IIb, Nonrandomized, Open-Label Trial With Mouse Renal Adenocarcinoma (RENCA) Cell Containing Agarose-Agarose Macrobeads Compared With Best Supportive Care in Patie

Brief Summary:

This is a clinical research study of an investigational (FDA IND-BB 10091) treatment for patients with advanced colorectal cancer that no longer responds to standard therapies.

The treatment is being evaluated for its effect on tumor growth. It consists of the placement (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA macrobeads). The cells in the macrobeads produce substances that have been shown to slow or stop the growth of tumors in experimental animals and veterinary patients. It has been tested in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II studies in patients with colorectal, pancreatic or prostate cancers are in progress


Detailed Summary:

This is a Phase IIb, multicenter, nonrandomized, open-label study with RENCA macrobeads in patients with treatment-resistant, metastatic colorectal carcinoma to determine the effect of RENCA macrobead implantation on overall survival compared with best supportive care.

Two treatment groups will be enrolled in this study, as follows:

  • Group A (n=40) - patients who will undergo up to 4 implantations of RENCA macrobeads, at an amount of 8 RENCA macrobeads /kg body weight
  • Group B (n=80) - patients who will receive or are receiving best supportive care, defined as management of symptoms aimed at maintaining or improving quality of life, but not including approved therapies targeting the patient's malignancy

Sponsor: The Rogosin Institute

Current Primary Outcome: Overall Survival [ Time Frame: 12 months ]

This study is to evaluate the efficacy of renal adenocarcinoma (RENCA) macrobead implantation compared with best supportive care, as assessed by overall survival


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in levels of tumor markers (CEA and CA19-9) [ Time Frame: 12 months ]
    Change from baseline over the period after the first RENCA macrobead implantation in levels of tumor markers (including carcinoembryonic antigen [CEA] and carbohydrate antigen 19-9 [CA19-9]
  • Change in clinical status, as measured by ECOG performance status score and Global clinical assessment [ Time Frame: 12 months ]
    Change from baseline over the period after the first RENCA macrobead implantation in clinical status, as measured by Eastern Cooperative Oncology Group (ECOG) performance status score and Global Clinical Assessment
  • Change in quality of life, as measured by the EORTC QLQ C30 Questionnaire [ Time Frame: 12 months ]
    Change from baseline over the period after the first RENCA macrobead implantation in quality of life, as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30)
  • Tumor marker response rate [ Time Frame: 12 months ]
    Tumor marker response rate, defined as the proportion of patients who have a decrease from baseline of 20% or more in CEA or CA 19-9 values
  • Change in quality of life, as measured by the KPS [ Time Frame: 12 months ]
    Change from baseline over the period after the first RENCA macrobead implantation in quality of life, as measured by the Karnofsky Performance Status Scale (KPS)


Original Secondary Outcome: Same as current

Information By: The Rogosin Institute

Dates:
Date Received: January 21, 2014
Date Started: January 2014
Date Completion: December 2019
Last Updated: May 3, 2017
Last Verified: May 2017