A Phase 1 interventional study of Cytochlor and Tetrahydrouridine in Brain and Central Nervous System Tumors, sponsored by Brian Lally. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2014-11-25.
Sponsored by Brian Lally · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of cytochlor.
Patients receive cytochlor IV and tetrahydrouridine (H4U) IV over 5 minutes on 3 days in week 1 and on days 1-5 in weeks 2 and 3. Patients also undergo external-beam radiotherapy 5 days a week in weeks 2 and 3 initiated 3-4 hours after infusions of cytochlor and H4U. Treatment may repeat in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed monthly for 3 months, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then yearly thereafter.
684 studies on the registry are indexed under Central Nervous System Neoplasms; 68 are open to participants now.
This study's enrollment of 2 is below the median of 35 across 474 interventional studies indexed under Central Nervous System Neoplasms.
Browse Central Nervous System Neoplasms studies →This is the only study on the registry with Brian Lally as lead sponsor.
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DISEASE CHARACTERISTICS:
Eligible for whole-brain radiotherapy (WBRT)
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No other concurrent anticancer therapy outside the protocol
Drug: Cytochlor · Drug: Tetrahydrouridine · Radiation: Radiation Therapy
The study's starting dose of CldC is 50 mg/m2/day. The dose of CldC will be escalated / de-escalated for patients. Patients will receive CldC+H4U on 3 days (Wed, Thr, Fri) in week 1, which precedes the initiation of radiation therapy. Patients will receive H4U and CldC IV by bolus infusion. Treatment with CldC+H4U will then continue for 5 days (Mon-Fri) during each of weeks 2 and 3, and will be accompanied by radiation therapy at 3 Gy/fraction initiated 3-4 h after bolus infusion of CldC+H4U. Treatment with CldC+H4U and radiation will then stop at the end of week 3.
Also known as: CldC, CDC
A fixed dose of H4U at 720 mg/m2/day will be used, regardless of the dose of CldC administered. H4U will be delivered by an IV bolus infusion over a period of 5 minutes, followed 5 minutes later by an IV bolus infusion of CldC. Patients will receive CldC+H4U on 3 days (Wed, Thr, Fri) in week 1, which precedes the initiation of radiation therapy. Patients will receive H4U and CldC IV by bolus infusion. Treatment with CldC+H4U will then continue for 5 days (Mon-Fri) during each of weeks 2 and 3, and will be accompanied by radiation therapy at 3 Gy/fraction initiated 3-4 h after bolus infusion of CldC+H4U. Treatment with CldC+H4U and radiation will then stop at the end of week 3.
Also known as: THU, H4U
One treatment of 3 Gy will be given daily 5 days per week (10 fractions) for a total of 30 Gy over two weeks.
To establish a dose range of CldC for further clinical studies (Phase II clinical trials) based on safety and toxicity.
Time frame: 2 Years
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.
Time frame: Duration of study treatment
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
Time frame: At protocol specified timepoints during treatment
Cytochlor and metabolite levels in serum at weeks 1, 2, and 3
Time frame: Pharmacokinetic sampling at protocol-specified timepoints during duration of treatment
Cytochlor and metabolite levels in urine at weeks 1, 2, and 3
Time frame: Pharmacokinetic sampling at protocol-specified timepoints during duration of treatment
The record gives a start of Jun 2007, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tetrahydrouridine
Central Nervous System Neoplasms →