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Investigator(s):
James Doroshow, M.D. Principal Investigator Phone: 301-496-4291	Shivaani Kummar, M.D. Protocol Chair Phone: 301-435-5402 kummars@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 jbingham@mail.nih.gov	Mary Ann Yancey, R.N. Research Nurse Phone: 301-435-9227 yanceym@mail.nih.gov

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Primary Eligibility:

• Patients with advanced, histologically-confirmed malignancies refractory to standard therapy or for which no standard therapy exists
• Patients should have adequate liver, renal, and bone marrow function
• All patients of child-bearing age, both male and female, must be advised to practice adequate contraception
• Premenopausal women must have a negative pregnancy test prior to entry on the study
• The presence of measurable disease is not required
• Patients must have adequate organ function, defined as a serum bilirubin ≤ 1.5 mg/dl, platelets ≥ 125, 000/μl, absolute neutrophil count ≥ 1500/μl and serum creatinine ≤ 2.0 mg/dl

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Treatment Plan:

• Study drug is administered using a 28-day repeating cycle as follows:
• 5-Fluoro-2-Deoxyctidine (FdCyd) and Tetrahydrouridine (THU) is administered by mouth on Day 1 of Cycle 1 only (for subsequent cycles, FdCyd will be administered as an intravenous infusion over 3 hours along with an infusion of THU)
• FdCyd is administered as an intravenous infusion over 3 hours, along with a daily infusion of THU for the following 4 consecutive days of treatment, followed by a 2-day break
• FdCyd is administered as an intravenous infusion over 3 hours along with a daily infusion of THU for the following 5 consecutive days of treatment
• No treatment for 2 weeks
• The dose of THU is fixed at 350 mg/m²/day; the dose of FdCyd will be escalated based on the tolerability of lower doses
• Three to six patients will be enrolled at each dose level
• Blood for pharmacodynamic studies will be obtained on Day 1, 2, 12, and 15 of Cycle 1, and on Day 1, 12, and 15 of all subsequent cycles
• No tumor biopsies will be performed

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 10/28/08
Updated: 11/14/08