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AzTrials

NeoplasmsPhase 2NCT02366884

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

A Phase 2 study testing Anti-Bacterial Agents, Anti-Fungal Agents and Anti-Protozoal Agents in people with Neoplasms, run by Dr. Frank Arguello Cancer Clinic at 2 sites in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 year to 75 years
Conditions the study is for
Neoplasms
What is being tested?
Anti-Bacterial Agents, Anti-Fungal Agents and Anti-Protozoal Agents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
2 sitesMexico
Study dates
26 Jul 2011to 31 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

Mexico2 sites, 2 recruiting

  • Dr. Frank Arguello Cancer Clinic

    San José del Cabo, Baja California Sur

    Frank Arguello, MD, (301) 760-7777, arguellof@atavisticchemotherapy.com

    Frank Arguello, MD

    Recruiting

  • Instituto de Ciencia y Medicina Genomica

    Torreón, Coahuila, 35000

    Enrolling by invitation

Other trials in Mexico

About this study

Official title: Atavistic Chemotherapy and Immunotherapy in Advanced, Metastatic, and Otherwise Incurable and Lethal Cancers Under Conventional Treatments

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.

Read more

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.

Read the 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.

Conditions
Neoplasms
Being tested
Anti-Bacterial Agents, Anti-Fungal Agents, Anti-Protozoal Agents
Keywords
malignant, atavistic chemotherapy, cancer
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-Bacterial AgentsDrug

    Doxycycline, Paramomycin, Clarithromycin, Clindamycin, Dapsone, Miltefosine

  • Anti-Fungal AgentsDrug

    Itraconazole, Amphotericin B liposomal, Fluconazole, Terbinafine, Voriconazole

  • Anti-Protozoal AgentsDrug

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

Study groups in NCT02366884
Study groupRoleWhat they receive
Anti-bacterial agentsExperimentalCombination of two selected anti-bacterial agents with documented anti-cancer properties
Receives: Drug: Anti-Bacterial Agents
Anti-fungal agentsExperimentalCombination of two selected anti-fungal agents with documented anti-cancer properties
Receives: Drug: Anti-Fungal Agents
Anti-protozoal agentsExperimentalCombination of two selected anti-protozoal agents with documented anti-cancer properties
Receives: Drug: Anti-Protozoal Agents
Anti-bacterial + anti-fungal + anti-protozoal agentsExperimentalCombination of six selected anti-bacterial agents, anti-fungal agents, and anti-protozoal agents with documented anti-cancer properties
Receives: Drug: Anti-Bacterial Agents; Drug: Anti-Fungal Agents; Drug: Anti-Protozoal Agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 Months

Secondary outcomes (2)

  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.

    Measured: 12 Months

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

    Determine the percentage of incidence of adverse events in each intervention group.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2015 (estimated)
  2. Study start26 Jul 2011
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02366884
Sponsor's protocol ID
ACI/2015
Status last verified
Mar 2022
First submitted
9 Feb 2015
Last updated
6 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 3180096

  • 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.

    PubMed 9516149

  • 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.

    PubMed 2293874

  • 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.

    PubMed 1559233

  • 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.

    PubMed 1428234

  • 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.

    PubMed 8639792

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anti-Bacterial Agents, Anti-Fungal Agents and Anti-Protozoal Agents in people with Neoplasms, run by Dr. Frank Arguello Cancer Clinic at 2 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical efficacy as measured by the number of participants with an objective clinical tumor regression response (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02366884, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.

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