Cytochlor, Tetrahydrouridine, and External-Beam Radiation Therapy in Treating Patients With Cancer That Has Spread to the Brain

Completed · Phase 1

Conditions studied: Brain and Central Nervous System Tumors

In brief

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as cytochlor and tetrahydrouridine, may make tumor cells more sensitive to radiation therapy. PURPOSE: This phase I trial is studying the side effects and best dose of cytochlor when given together with tetrahydrouridine and external-beam radiation therapy in treating patients with cancer that has spread to the brain.

Key facts

Study ID

NCT00521183

Run by

Brian Lally

People needed

2

Starts

2007-06-01

Expected to finish

2014-05-01

Last updated by the study team

2014-11-25

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Karnofsky performance status (PS) 70-100% or ECOG PS 0-1
• Leukocytes ≥ 3,000/µL
• Absolute neutrophil count > 1,500/µL
• Platelet count > 100,000/µL
• Total bilirubin normal
• AST and ALT < 2.5 times upper limit of normal
• Creatinine normal OR creatinine clearance > 60 mL/min
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation

You may not qualify if…

• Uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or lactating
• Alcohol dependence
• PRIOR CONCURRENT THERAPY:
• No prior radiotherapy to the brain
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), or other experimental medication
• No other concurrent anticancer therapy outside the protocol
• Systemic therapy one month before or after brain radiotherapy is allowed
• No concurrent heparin or coumadin

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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