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

NCT02366884 | Unknown Phase 2

• 1 other identifier: ACI/2015
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Neoplasms

Keywords

malignant; atavistic chemotherapy; cancer

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy as measured by the number of participants with an objective clinical tumor regression response

  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.

  6 Months

Secondary Outcomes (2)

• Clinical efficacy as measured by the number of participants with an objective clinical tumor regression response

  12 Months

• Clinical safety as measured by the incidence of adverse events in each intervention group

  12 Months

Study Arms (4)

Anti-bacterial agents

EXPERIMENTAL

Combination of two selected anti-bacterial agents with documented anti-cancer properties

Drug: Anti-Bacterial Agents

Anti-fungal agents

EXPERIMENTAL

Combination of two selected anti-fungal agents with documented anti-cancer properties

Drug: Anti-Fungal Agents

Anti-protozoal agents

EXPERIMENTAL

Combination of two selected anti-protozoal agents with documented anti-cancer properties

Drug: Anti-Protozoal Agents

Anti-bacterial + anti-fungal + anti-protozoal agents

EXPERIMENTAL

Combination of six selected anti-bacterial agents, anti-fungal agents, and anti-protozoal agents with documented anti-cancer properties

Drug: Anti-Bacterial Agents; Drug: Anti-Fungal Agents; Drug: Anti-Protozoal Agents

Interventions

Anti-Bacterial Agents DRUG

Doxycycline, Paramomycin, Clarithromycin, Clindamycin, Dapsone, Miltefosine

Anti-bacterial + anti-fungal + anti-protozoal agents; Anti-bacterial agents

Anti-Fungal Agents DRUG

Itraconazole, Amphotericin B liposomal, Fluconazole, Terbinafine, Voriconazole

Anti-bacterial + anti-fungal + anti-protozoal agents; Anti-fungal agents

Anti-Protozoal Agents DRUG

Nitazoxanide, Chloroquine, Albendazole, Ivermectin, Mebendazole, Metronidazole, Praziquantel, Levamisole

Anti-bacterial + anti-fungal + anti-protozoal agents; Anti-protozoal agents

Eligibility Criteria

• Age: 1 Year - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr. Frank Arguello Cancer Clinic: lead
• Instituto de Ciencia y Medicina Genomica, Torreon, Coah. Mexico www.institutodeciencia.com: collaborator

Study Sites (2)

Dr. Frank Arguello Cancer Clinic

San José del Cabo, Baja California Sur, Mexico

RECRUITING

Instituto de Ciencia y Medicina Genomica

Torreón, Coahuila, 35000, Mexico

ENROLLING BY INVITATION

Related Publications (6)

• Arguello F, Baggs RB, Frantz CN. A murine model of experimental metastasis to bone and bone marrow. Cancer Res. 1988 Dec 1;48(23):6876-81.

  PMID: 3180096 BACKGROUND

• Arguello F, Alexander M, Sterry JA, Tudor G, Smith EM, Kalavar NT, Greene JF Jr, Koss W, Morgan CD, Stinson SF, Siford TJ, Alvord WG, Klabansky RL, Sausville EA. Flavopiridol induces apoptosis of normal lymphoid cells, causes immunosuppression, and has potent antitumor activity In vivo against human leukemia and lymphoma xenografts. Blood. 1998 Apr 1;91(7):2482-90.

  PMID: 9516149 BACKGROUND

• Arguello F, Baggs RB, Duerst RE, Johnstone L, McQueen K, Frantz CN. Pathogenesis of vertebral metastasis and epidural spinal cord compression. Cancer. 1990 Jan 1;65(1):98-106. doi: 10.1002/1097-0142(19900101)65:13.0.co;2-k.

  PMID: 2293874 BACKGROUND

• Arguello F, Furlanetto RW, Baggs RB, Graves BT, Harwell SE, Cohen HJ, Frantz CN. Incidence and distribution of experimental metastases in mutant mice with defective organ microenvironments (genotypes Sl/Sld and W/Wv). Cancer Res. 1992 Apr 15;52(8):2304-9.

  PMID: 1559233 BACKGROUND

• Arguello F, Baggs RB, Graves BT, Harwell SE, Cohen HJ, Frantz CN. Effect of IL-1 on experimental bone/bone-marrow metastases. Int J Cancer. 1992 Nov 11;52(5):802-7. doi: 10.1002/ijc.2910520522.

  PMID: 1428234 BACKGROUND

• Arguello F, Sterry JA, Zhao YZ, Alexander MR, Shoemaker RH, Cohen HJ. Two serologic markers to monitor the engraftment, growth, and treatment response of human leukemias in severe combined immunodeficient mice. Blood. 1996 May 15;87(10):4325-32.

  PMID: 8639792 BACKGROUND

Related Links

• STAGE IV MELANOMA PATIENTS TREATED WITH ATAVISTIC CHEMOTHERAPY
• STAGE IV BREAST CANCER PATIENTS TREATED WITH ATAVISTIC CHEMOTHERAPY
• What is Atavistic Chemotherapy?
• Website Atavistic Chemotherapy
• Facts of Evolution

MeSH Terms

Conditions

Neoplasms

Interventions

Anti-Bacterial Agents; Antifungal Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Frank Arguello, MD

  Dr. Frank Arguello Cancer Clinic

  PRINCIPAL INVESTIGATOR

• Rafael Argüello-Astorga, MD, PhD

  Instituto de Ciencia y Medicina Genomica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 19, 2015
• Study Start: July 26, 2011
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)