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Eligibility Criteria

Below are some general eligibility guidelines and criteria to help determine whether or not you would be eligible to participate in a Phase I clinical trial at M. D. Anderson Cancer Center. These criteria vary from study to study. Specific conditions for a particular study will be discussed with you by the study physician or authorized medical staff.

Inclusion Criteria

  1. Participants must be able to understand and sign the Informed Consent, and comply with all aspects of the protocol.
  2. Participants must have documented evidence of malignancy and must have failed or relapsed following standard therapy or have no standard therapy available.
  3. Participants must have measurable or evaluable disease.
  4. Participants must have a life expectancy of greater than or equal to 12 weeks.
  5. Women of childbearing potential must have a negative pregnancy test. Because the risks to unborn fetuses are unknown, both male and female participants must use a barrier method of contraception.
  6. Participants must have adequate performance status.
  7. Participants must have adequate organ function (i.e., kidney, liver and heart) and/or bone marrow function.
  8. Participants must have recovered from any toxicities from prior therapies. In addition, participants should not have had prior therapies within four weeks of beginning a new Phase I therapy.
  9. Many Phase I therapies are limited to participants aged 18 or older.

Exclusion Criteria

  1. Patients with insufficient organ and/or bone marrow function.
  2. Patients who have had other chemotherapies or other investigational agents/therapies within 28 days of the study.
  3. Patients with low blood counts.
  4. Patients with an uncontrolled medical condition (i.e., hypertension, cardiac arrhythmias, CHF and COPD) that places the patient at risk by participating in the study.
  5. Patients with a clinically significant infection that is chronic, recurrent or active.
  6. Pregnant or lactating women or patients (male or female) who do not use a barrier method of contraception.
  7. Patients with uncontrolled brain metastases or central nervous system disease.
  8. Patients with known HIV, hepatitis B or hepatitis C infection, or autoimmune diseases.
  9. Patients who are hypersensitive to the study drug or may be taking concomitant medications that are contraindicative to the study drug will be excluded.

Contact Us

Christie Carver-FryerFor a referral to Phase I clinical trials, contact Patient Access Supervisor Christie Carver-Fryer at (713) 792-1160, or visit our Appointments & Referrals page.


© 2009 The University of Texas M. D. Anderson Cancer Center