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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 February 2021
• Main ID: NCT02366884
• Date of registration: 09/02/2015
• Prospective Registration: No
• Primary sponsor: Dr. Frank Arguello Cancer Clinic
• Public title: Clinical Evaluation of a New Form of Cancer Therapy Based on the Principles of Atavistic Metamorphosis (Atavistic Chemotherapy).
• Scientific title: Atavistic Chemotherapy and Immunotherapy in Advanced, Metastatic, and Otherwise Incurable and Lethal Cancers Under Conventional Treatments
• Date of first enrolment: July 2011
• Target sample size: 250
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02366884
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 2

Countries of recruitment

Mexico, United States

Contacts

• Name: Frank Arguello, MD
• Affiliation: Dr. Frank Arguello Cancer Clinic

• Name: Rafael Argüello-Astorga, MD, PhD

• Name: Rafael Argüello-Astorga, MD, PhD
• Affiliation: Instituto de Ciencia y Medicina Genomica

Key inclusion & exclusion 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)



Age minimum: 1 Year
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Neoplasms

Intervention(s)

Drug: Anti-Fungal Agents

Drug: Anti-Bacterial Agents

Drug: Anti-Protozoal Agents

Primary Outcome(s)

Clinical efficacy as measured by the number of participants with an objective clinical tumor regression response [Time Frame: 6 Months]

Secondary Outcome(s)

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

Clinical efficacy as measured by the number of participants with an objective clinical tumor regression response [Time Frame: 12 Months]

Secondary ID(s)

ACI/2015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Instituto de Ciencia y Medicina Genomica, Torreon, Coah. Mexico www.institutodeciencia.com