Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283075
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2006-01-26
Brief Title:
Mouse Cancer Cell-containing Macrobeads in the Treatment of Human Cancer
Sponsor:
The Rogosin Institute
Organization:
The Rogosin Institute
Study Overview
Official Title:
Use of Mouse Renal Adenocarcinoma Cell-containing Agarose-agarose Macrobeads in the Treatment of Patients With End-stage Treatment-resistant Epithelial-derived Cancer
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 US health problem accounting for 550000 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 andor 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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None