Clinical Evaluation of a New Form of Cancer Therapy (Atavistic Chemotherapy) Based on the Principles of Atavistic Metamorphosis (2011)
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ClinicalTrials.gov Identifier: NCT02366884 |
Recruitment Status : Unknown
Verified March 2022 by Frank Arguello, MD, Dr. Frank Arguello Cancer Clinic.
Recruitment status was: Recruiting
First Posted : February 19, 2015
Last Update Posted : April 6, 2022
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Tracking Information | |||||||
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First Submitted Date ICMJE | February 9, 2015 | ||||||
First Posted Date ICMJE | February 19, 2015 | ||||||
Last Update Posted Date | April 6, 2022 | ||||||
Actual Study Start Date ICMJE | July 26, 2011 | ||||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Clinical efficacy as measured by the number of participants with an objective clinical tumor regression response [ Time Frame: 6 Months ] Tumor regression will be measrued objectively and assessments appropriate for the type of cancer treated. Outcome measures may include 1) Changes in signs and symptoms; (2) Visual inspection of tumors using weekly photographs and measurements (as appropriate); (3)Monthly chest X-rays to monitor lung tumors, lung metastases and/or fluid in the chest; (4) Ultrasound to evaluate abdominal tumors (e.g., liver metastases), and breast and armpit lymph nodes; (5) CT, MRI and PET scans; (6) Tumor markers in blood such as Carcinoembryonic Antigen (CEA), CA-15.3, CA-19-9 and other laboratory studies to monitor response.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Clinical Evaluation of a New Form of Cancer Therapy (Atavistic Chemotherapy) Based on the Principles of Atavistic Metamorphosis (2011) | ||||||
Official Title ICMJE | Atavistic Chemotherapy and Immunotherapy in Advanced, Metastatic, and Otherwise Incurable and Lethal Cancers Under Conventional Treatments | ||||||
Brief Summary | The cell behavior that the investigators regard as "malignant," including: cell autonomy; invasion and digestion of surrounding normal tissues; migration and colonization of distant organs; ability to develop resistance to drugs, temperature, or radiation; and ability to kill the host, are not only characteristics of cancer cells, but of pathogenic and/or opportunistic unicellular organisms (bacteria, fungi and protozoa). Rudolf Virchow (1821-1902), the father of modern pathology, first pointed out the resemblance between the biological behavior of cancer cells and that of single-celled organisms when causing infections. He thought, incorrectly, that cancer cells were cells infected with bacteria and had acquired their pathogenic behavior from them. Others later postulated that the behavior of cancer cells was likely due to the re-expression of past traits and behaviors (atavism) derived from their past evolutionary experience as independent, single-celled organisms from which all cells in multicellular organisms originated. In other words, the behavior of pathogenic unicellular organisms, including: unlimited replicative potential; capacity for invasion, migration, and metastases; abilities to evade the host's immune system, to generate multi-drug resistance; and to kill a host, are what the investigators define as "cancer" when one of the investigators cells re-express these past ancestral traits. This reversion or de-evolution of a differentiated cell to its ancestral undifferentiated, unicellular form has been named "Atavistic Metamorphosis." This does not imply that cancer cells are bacteria, protozoa, or yeasts. It means that cancer cells express functions and/or behaviors similar to their ancestral parents, the unicellular organisms from which our cells originated. If this is true, a combination of drugs that are effective to eradicate certain unicellular organisms may work in cancer treatment. The principal objective of this study is to determine whether there is a benefit for patients with advanced, metastatic and terminal cancers to be treated with combinations of selected drugs conventionally used in medical practice to kill bacterial, fungal and protozoal cells. |
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Detailed Description | This is an investigator initiated, randomized, single-blind, response-adaptive trial conducted at two sites in patients who have tried conventional therapy and failed or have refused conventional therapy. This study is being conducted to determine the efficacy of combinations of marketed drugs against unicellular organisms in cancer treatment. The products under investigation include FDA- and SSA-approved anti-bacterial, anti-fungal and anti-protozoan drugs with documented anti-cancer properties. The drugs under study are compatible with each other, and used at pharmacological dosages known to be tolerable and safe in humans and/or cancer patients with limited adverse effects. Patients receive treatment for 10 to 12 months. The duration of treatment is depended on the drugs investigated. It is hypothesized that regression will occur within 6 months and treatment will be continued with the assumption that this may prevent recurrences. Outcomes will be measured objectively and assessments appropriate for the type of cancer treated. Outcome measures may include 1) Changes in signs and symptoms; (2) Visual inspection of tumors using weekly photographs and measurements (as appropriate); (3)Monthly chest X-rays to monitor lung tumors, lung metastases and/or fluid in the chest; (4) Ultrasound to evaluate abdominal tumors (e.g., liver metastases), and breast and armpit lymph nodes; (5) CT, MRI and PET scans; (6) Tumor markers in blood such as Carcinoembryonic Antigen (CEA), CA-15.3, CA-19-9, etc. and other laboratory studies to monitor response. The overall goal of this study is to understand the efficacy of atavistic chemotherapy that may mediate metastatic or terminal cancer regression or cure. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Neoplasms | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Estimated Enrollment ICMJE |
250 | ||||||
Original Estimated Enrollment ICMJE |
100 | ||||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year to 75 Years (Child, Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Mexico | ||||||
Removed Location Countries | United States | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02366884 | ||||||
Other Study ID Numbers ICMJE | ACI/2015 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Frank Arguello, MD, Dr. Frank Arguello Cancer Clinic | ||||||
Original Responsible Party | Dr. Frank Arguello Cancer Clinic | ||||||
Current Study Sponsor ICMJE | Dr. Frank Arguello Cancer Clinic | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Instituto de Ciencia y Medicina Genomica, Torreon, Coah. Mexico www.institutodeciencia.com | ||||||
Investigators ICMJE |
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PRS Account | Dr. Frank Arguello Cancer Clinic | ||||||
Verification Date | March 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |