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Clinical Evaluation of a New Form of Cancer Therapy (Atavistic Chemotherapy) Based on the Principles of Atavistic Metamorphosis (2011)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02366884
Recruitment Status : Recruiting
First Posted : February 19, 2015
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
Instituto de Ciencia y Medicina Genomica, Torreon, Coah. Mexico www.institutodeciencia.com
Information provided by (Responsible Party):
Frank Arguello, MD, Dr. Frank Arguello Cancer Clinic

Study Description
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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.


Condition or disease Intervention/treatment Phase
Neoplasms Drug: Anti-Bacterial Agents Drug: Anti-Fungal Agents Drug: Anti-Protozoal Agents Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Atavistic Chemotherapy and Immunotherapy in Advanced, Metastatic, and Otherwise Incurable and Lethal Cancers Under Conventional Treatments
Actual Study Start Date : July 26, 2011
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Anti-bacterial agents
Combination of two selected anti-bacterial agents with documented anti-cancer properties
 Drug: Anti-Bacterial Agents
Doxycycline, Paramomycin, Clarithromycin, Clindamycin, Dapsone, Miltefosine
Experimental: Anti-fungal agents
Combination of two selected anti-fungal agents with documented anti-cancer properties
 Drug: Anti-Fungal Agents
Itraconazole, Amphotericin B liposomal, Fluconazole, Terbinafine, Voriconazole
Experimental: Anti-protozoal agents
Combination of two selected anti-protozoal agents with documented anti-cancer properties
 Drug: Anti-Protozoal Agents
Nitazoxanide, Chloroquine, Albendazole, Ivermectin, Mebendazole, Metronidazole, Praziquantel, Levamisole
Experimental: Anti-bacterial + anti-fungal + anti-protozoal agents
Combination of six selected anti-bacterial agents, anti-fungal agents, and anti-protozoal agents with documented anti-cancer properties
 Drug: Anti-Bacterial Agents
Doxycycline, Paramomycin, Clarithromycin, Clindamycin, Dapsone, Miltefosine

Drug: Anti-Fungal Agents
Itraconazole, Amphotericin B liposomal, Fluconazole, Terbinafine, Voriconazole

Drug: Anti-Protozoal Agents
Nitazoxanide, Chloroquine, Albendazole, Ivermectin, Mebendazole, Metronidazole, Praziquantel, Levamisole


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical efficacy as measured by the number of participants with an objective clinical tumor regression response [ Time Frame: 12 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.

  2. Clinical safety as measured by the incidence of adverse events in each intervention group [ Time Frame: 12 Months ]
    Determine the percentage of incidence of adverse events in each intervention group.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with malignant disease confirmed histologically that is considered untreatable, progressive and fatal within the next 16 months.
  • Patient with an expectation of life greater than 3 months.
  • Patients with malignant disease that may be evaluated or measured clinically either through radiographic studies, visually, histologically, in serum or blood tumor markers, or through any other method medical approved for that disease.

Exclusion Criteria:

  • Patients over 75 years of age.
  • Patients who are pregnant.
  • Patients that have a known allergy to any of the drugs planned for use.
  • Patients with renal, hepatic, pulmonary, cardiovascular compromise, or other systemic or other clinical conditions such as AIDS, tuberculosis, etc., which, in the opinion of the Investigator, may pose a risk to the subject.
  • Malignancies of hemato-lymphatic origin (leukemias and lymphomas)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02366884


Locations
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Mexico
Dr. Frank Arguello Cancer Clinic Recruiting
San Jose del Cabo, Baja California Sur, Mexico
Contact: Frank Arguello, MD    (301) 760-7777    arguellof@atavisticchemotherapy.com   
Principal Investigator: Frank Arguello, MD         
Instituto de Ciencia y Medicina Genomica Enrolling by invitation
Torreon, Coahuila, Mexico, 35000
Sponsors and Collaborators
Dr. Frank Arguello Cancer Clinic
Instituto de Ciencia y Medicina Genomica, Torreon, Coah. Mexico www.institutodeciencia.com
Investigators
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Principal Investigator: Frank Arguello, MD Dr. Frank Arguello Cancer Clinic
Principal Investigator: Rafael Argüello-Astorga, MD, PhD Instituto de Ciencia y Medicina Genomica
More Information
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Additional Information:

Publications:

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Responsible Party: Frank Arguello, MD, Director, Dr. Frank Arguello Cancer Clinic
ClinicalTrials.gov Identifier: NCT02366884    
Other Study ID Numbers: ACI/2015
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frank Arguello, MD, Dr. Frank Arguello Cancer Clinic:
malignant
atavistic chemotherapy
cancer
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antifungal Agents
Clotrimazole
Miconazole
Antiprotozoal Agents
Anti-Infective Agents
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Antiparasitic Agents