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Last Updated: 06/22/15

Eligibility Criteria

Every clinical trial has a protocol, or action plan, that describes what will be done in the trial, how the trial will be conducted, and why each part of the trial is necessary. The protocol also includes guidelines for who can and cannot participate in the trial. These guidelines, called eligibility criteria, describe the characteristics that all interested people must have before they can take part in the trial. Eligibility criteria can include age, sex, medical history, and current health status. Eligibility criteria for cancer treatment trials often include the type and stage of cancer, as well as the type(s) of cancer treatment already received.

Enrolling people who have similar characteristics helps ensure that the outcome of a trial is due to the intervention being tested and not to other factors. In this way, eligibility criteria help researchers obtain the most accurate and meaningful results possible.

General Eligibility Criteria *

* Some studies may have further eligibility requirements

Adult patients (age 18 years or older)

  • Metastatic or unresectable solid tumor malignancy or low grade lymphoma, refractory to standard therapies
  • No limit on prior therapies received
  • Prior anticancer therapy must have been completed ≥ 4 weeks prior to starting study drug
  • Must have measurable (for phase II studies) or evaluable disease
  • Must have normal or adequate organ and bone marrow function as defined below:
    • Absolute neutrophil count > 1,500
    • Platelets > 100,000
    • Total bilirubin < 1.5x institutional upper limit normal (ULN)
    • AS/ALT < 2. 5 - 3x ULN (Options for patients with liver dysfunction may be available)
    • Creatinine < 1.5x institutional upper limits OR creatinine clearance > 60 ml/min
  • Women of child-bearing potential and men must agree to use adequate contraception
  • Willingness to sign a written informed consent document
  • Patients with uncontrolled intercurrent illness, unstable heart disease, unstable brain metastases, or who are pregnant or nursing are not eligible for a trial