Mouse Cancer Cell-containing Macrobeads in the Treatment of Human Cancer
Condition: Intraabdominal Cancers (Various Types)
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 trial to evaluate the safety and toxicity of mouse kidney cancer
      cell-containing agarose-agarose macrobeads that are implanted in the abdominal cavity as a
      proposed biological treatment of patients with end-stage, treatment-resistant cancer. The
      macrobeads have been extensively tested in tumor models in mice and rats, as well as in
      forty-five veterinary patients (cats and dogs) with naturally occurring tumors of various
      types including breast cancer, prostate cancer, liver cancer, and lymphoma with clear tumor
      responses and no significant detectable toxicity.
    

Detailed description: 
      Cancer in its various forms continues to be a major U.S. health problem, accounting for
      550,000 deaths a year, as well as much disability and suffering. Treatment for cancer has
      traditionally consisted of three modalities: surgery, radiation therapy, and chemotherapy.
      Advances with all three modalities over the years have produced long-term remissions and/or
      cures in certain types of cancer such as the leukemias, and prolonged survival for many other
      patients. Much remains to be accomplished, however, especially with respect to the treatment
      of solid tumors, including some of the most common cancers such as those of the lung, colon,
      breast, ovary, prostate and kidney. New types of less toxic and debilitating therapy are
      needed.

      Among the therapeutic possibilities currently being explored, those that involve biological
      control mechanisms seem both promising and attractive. Although it has long been thought that
      cancer cells are not subject to the same regulatory growth control mechanisms that function
      in normal cells, there is a substantial body of evidence that they can respond to feedback
      signals telling them to slow or stop their growth. In addition, it has been determined that a
      relatively small population of cells within a tumor (cancer "stem" or progenitor cells) are
      responsible for continued tumor growth and that it is these cells that must be controlled if
      biological anti-tumor therapy is to be effective.

      The proposed cancer treatment being tested in this Phase 1 clinical trial is based on the
      concept that tumor growth can be controlled by tumor mass or signals that indicate that such
      mass is present. In this case, however, the induction of the growth-slowing signals is
      brought about not by tumor mass, but by placing mouse kidney cancer cells in an agarose
      matrix, which both selects for cancer progenitor cells and also causes them to produce and
      release signals that inhibit the growth of freely growing cancer cells of the same or
      different type in a laboratory dish or in a tumor-bearing animal or human (i.e. is also not
      species-specific). This approach has proven both safe and effective in animal models and
      veterinary patients, and it is now in the first stage of human testing. With Phase 1
      completed, we are now implementing Phase 2 efficacy trials that for the present are focused
      on colorectal cancer, pancreatic cancer, and prostate cancer. The Phase 1 trial remains open
      to a range of epithelial-derived cancer.
    

Intervention name(s): Cancer Macrobead placement in abdominal cavity
Intervention type(s): Biological
Intervention description(s): 8 macrobeads per kg
Other intervention name(s): cancer macrobead
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intraabdominal cancer (carcinomas); agarose macrobeads; mouse kidney cancer cells; cancer cell growth inhibition