An Early Phase I Study of IPdR Absorption, Metabolism, and Safety in Patients With Advanced Solid Tumors and Lymphomas

This is an interventional treatment trial for Neoplasms focused on measuring IPdR, Pharmacokinetics, Early Phase I, Cancer, Solid Tumor, Lymphoma Read More

• INCLUSION CRITERIA:
• Patients must have histologically documented (confirmed at the Laboratory of Pathology, NCI) solid tumors or lymphoid malignancies that are refractory to at least one line of standard treatment or for which no standard therapy is available. Patients with lymphoid malignancies may be enrolled if they have disease for which standard therapy is currently not indicated. Patients should not have disease-associated symptoms requiring immediate therapy or intervention.
• Any prior chemotherapy or radiation therapy must have been completed greater than or equal to 2 weeks prior to enrollment (6 weeks for nitrosoureas or mitomycin C), and the patient must have recovered to eligibility levels from prior toxicity.
• Age greater than or equal to 18 years. Patients under 18 years of age are excluded because of their inability as a protected population to give appropriate consent to this non-therapeutic study.
• ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
• Life expectancy of at least 3 months.

• Patients must have normal organ and marrow function as defined below:

  • absolute neutrophil count greater than or equal to 1,500/microL
  • platelets greater than or equal to 100,000/microL
  • total bilirubin less than 1.5 times institutional upper limit of normal (ULN)
  • AST(SGOT)/ALT(SGPT) less than or equal to 3.0 times ULN
  • creatinine less than 1.5 times ULN

OR:

--creatinine clearance greater than or equal to 60 mL/min for patients with creatinine levels greater than or equal to 1.5 times ULN

• IPdR is a nucleoside analog and therefore potentially teratogenic. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 30 days after study drug administration. Because there is an unknown but potential risk for adverse events in nursing infants secondary to IPdR administration to the mother, nursing mothers should not receive IPdR.
• Ability to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

• Patients may not be receiving any other investigational agents.
• Uncontrolled intercurrent illness including, but not limited to, ongoing uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, GI conditions limiting absorption, serious skin conditions, or psychiatric illness/social situations that would limit compliance with study requirements.
• Women who are pregnant or nursing.

INCLUSION OF WOMEN AND MINORITIES:

-Both men and women and members of all races and ethnic groups are eligible for this trial.