Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 1 of 1 for:    NCT02366884
Previous Study | Return to List | Next Study

Clinical Evaluation of a New Form of Cancer Therapy Based on the Principles of Atavistic Metamorphosis

This study is enrolling participants by invitation only.
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
ClinicalTrials.gov Identifier:
NCT02366884
First received: February 9, 2015
Last updated: February 18, 2017
Last verified: February 2017
  Purpose

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 Intervention Phase
Neoplasms
Drug: Anti-Bacterial Agents
Drug: Anti-Fungal Agents
Drug: Anti-Protozoal Agents
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: Atavistic Chemotherapy and Immunotherapy in Advanced, Metastatic, and Otherwise Incurable and Lethal Cancers Under Conventional Treatments

Resource links provided by NLM:


Further study details as provided by Dr. Frank Arguello Cancer Clinic:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02366884

Locations
United States, Maryland
Atavistic Chemotherapy Clinical Trial
Bethesda, Maryland, United States, 20814
Mexico
Dr. Frank Arguello Cancer Clinic
San Jose del Cabo, Baja California Sur, Mexico
Instituto de Ciencia y Medicina Genomica
Torreon, Coahuila, Mexico
Sponsors and Collaborators
Dr. Frank Arguello Cancer Clinic
Instituto de Ciencia y Medicina Genomica, Torreon, Coah. Mexico www.institutodeciencia.com
Investigators
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

Responsible Party: Frank Arguello, MD, Director, Dr. Frank Arguello Cancer Clinic
ClinicalTrials.gov Identifier: NCT02366884     History of Changes
Other Study ID Numbers: ACI/2015
Study First Received: February 9, 2015
Last Updated: February 18, 2017

Keywords provided by Dr. Frank Arguello Cancer Clinic:
malignant
atavistic chemotherapy
cancer

Additional relevant MeSH terms:
Antiprotozoal Agents
Antifungal Agents
Miconazole
Anti-Bacterial Agents
Antiparasitic Agents
Anti-Infective Agents
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

ClinicalTrials.gov processed this record on April 21, 2017