INFORMED CONSENT AND ENROLLMENT

This is NOT an alternative treatment for cancer, but simply a clinical trial to evaluate a new form of drug-based therapy that we believe is the correct way to treat cancer based on the biological origin and behavior of cancer cells. This is a clinical study registered with the National Institutes of Health (USA) under the identifier: NCT02366884 (www.clinicaltrials.gov). This study was initiated in 2011, and it is NOT being sponsored by any pharmaceutical company. All drugs involved are already in the market and available worldwide. It has been financed and sponsored in its entirety by the Arguello brothers. This is a not-for-profit activity, and patients pay only for the cost of the drugs involved in their treatment and services ($1,500 USD/month).

If your oncologist is willing to prescribe the medications for you in your country of origin, there are no fees or cost to help your oncologist to carry out the treatment. If you are interested in undergoing atavistic chemotherapy to treat your cancer, please review the material contained in our website, particularly the “Patient Information Package” contained in the PATIENT PORTAL, and contact us with any questions or concerns. The information contained in that package will answer many of your initial questions.

Also, make a list of any questions you have to which you don’t see the answer. When you are ready, Dr. Frank Arguello may be contacted as follows:

EmailArguelloF@AtavisticChemotherapy.com

Phone: (301) 305-9591 (Maryland, USA)

Not all clinical trials are right for all patients. A trial may be safe for one patient to join, but not safe for another. Each protocol has strict rules that we must follow to decide who may join the clinical trial. These rules are called eligibility criteria. This protects patients from getting treatment that may harm them.

Eligibility criteria for our trial include:

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, lymphomas and myelomas)

Dr. Arguello will communicate with you at length to determine whether you are a good candidate for treatment.

The Informed Consent Process

  • All patients must read, understand in full, and complete an Informed Consent Form, accepting treatment with atavistic chemotherapy’s benefits and potential risks, if any.
  • The purpose of the informed consent process is mainly to protect the patient. However, it also provides the doctor with evidence that you understand and accept that the treatment fulfills ethical and legal requirements.
  • Please note that a capable adult cannot be forced to take any type of medical treatment, conventional or non-conventional. In general, anything other than a life-threatening emergency in which the patient is unconscious requires consent before treatment.
  • Informed consent assumes that you are legally able to make your own decisions. If you are not, the person who is legally allowed to make decisions for you undergoes the informed consent process on your behalf.
  • For informed consent to take place, the information that is given must be understood. This responsibility is shared by the patient, since the doctor can’t know what you don’t understand unless you ask about it. You will have the chance to consider the information and ask questions. However, making these questions known is your responsibility.
  • Informed consent assumes that when you make your decision, you are not pressured. Rather, you are making a free choice, based on what you feel is best for you.
  • Even when there are no other acceptable medical treatment options, it is still your right as a competent adult to refuse a treatment that you do not want. You may also refuse to be in a study. However, once you sign the consent form, it is taken to be your formal, legal agreement that you consent to the plan or procedures listed, unless you revoke (take back) your consent before treatment is given.
  • You will receive a copy of the consent form. The clinic retains the original as a legal record of your agreement to the treatment.
  • All patients in clinical trials are volunteers. You can choose to quit a clinical trial at any time, but talk to your doctor first. Your doctor can tell you how quitting the trial might affect your health and if there are other treatment options. Your relationship with your health care providers will not be changed by your decision.

The Enrollment Process

Once you have read all the above information and discussed your case with Dr. Arguello, and you or your relatives have asked all questions, we may proceed with the Registration and Informed Consent process.

Please click this link to register and complete the consent form:

REGISTER & INFORMED CONSENT FORM.

After your registration and consent form are completed, click the button “SUBMIT.” You will automatically receive an e-mail with a random password and login information.

Your registration will be evaluated by Dr. Arguello. If he has additional questions for you, and/or if he needs to obtain specific reports, CDs, or studies, he will let you know.

Once approved, again log in to the site to change the password, if you wish to do so. You will also have private access to your medical file, schemes of treatment, communications between you and Dr. Arguello, etc.

Wishing you many more beautiful years,