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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brian Lally
• Treatments: Tetrahydrouridine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic cancer to the brain by contrast-enhanced MRI or CT scan

• Eligible for whole-brain radiotherapy (WBRT)

• Patients treated with prior surgery are eligible if WBRT is to be used post operatively

• Not planning to be treated with stereotactic radiosurgery

• No leptomeningeal metastasis documented by contrast-enhanced MRI/CT scan or cerebrospinal fluid evaluation

PATIENT CHARACTERISTICS:

Inclusion criteria:

• 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

Exclusion criteria:

• 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