Clinical trial · Interventional
Cytochlor, Tetrahydrouridine, and External-Beam Radiation Therapy in Treating Patients With Cancer That Has Spread to the Brain
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytochlor | Drug | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Tetrahydrouridine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CldC + H4U
- interventionNames
- Drug: Cytochlor
- Drug: Tetrahydrouridine
- Radiation: Radiation Therapy
Primary outcomes (2)
- measure
- To establish a dose range of CldC for further clinical studies (Phase II clinical trials) based on safety and toxicity.
- timeFrame
- 2 Years
- measure
- 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.
- timeFrame
- Duration of study treatment
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available