Brain and Central Nervous System Tumors Clinical Trial
Official title:
Translational Phase I Trial of Escalating Doses of 5-Chloro-2'-Deoxycytidine (CldC) With a Fixed Dose of Tetrahydrouridine Combined With External Brain Radiation for Metastatic Carcinoma to the Brain
Verified date | November 2014 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Brian Lally |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To establish a dose range of CldC for further clinical studies (Phase II clinical trials) based on safety and toxicity. | 2 Years | No | |
Primary | b) Establish the safety and toxicity profile of CldC+ H4U when given in combination with RT for 2 weeks following treatment with the drug alone for 3 days in the week prior to the combined treatment. | Duration of study treatment | Yes | |
Secondary | a) Determine the effectiveness of H4U to inhibit systemic cytidine deaminase (CD) during the course of treatment with CldC + H4U. | Baseline Levels of CD will be obtained by assaying CD in serum prior to initiation of treatment on Wednesday of week 1. Follow-up assays of CD in serum will be made on the Fridays of weeks 1 to 3 after each day's treatment with CldC + H4U. In weeks 2 and 3 this will take place prior to RT | At protocol specified timepoints during treatment | No |
Secondary | Cytochlor and metabolite levels in serum at weeks 1, 2, and 3 | Pharmacokinetic sampling at protocol-specified timepoints during duration of treatment | No | |
Secondary | Cytochlor and metabolite levels in urine at weeks 1, 2, and 3 | Pharmacokinetic sampling at protocol-specified timepoints during duration of treatment | No |
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