Experimental medicine, ropidoxuridine and whole brain radiation therapy in treating patients with brain metastases

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"Does experimental medicine, ropidoxuridine make cancer cells more easily killed by radiation therapy?"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
brain cancer, radiation
Type:
Other study, Phase 1
Investigator:
Description
This study looks at the side effects and best dose of experimental medicine, ropidoxuridine when given together with whole brain radiation therapy in treating patients with cancer that has spread to the brain. Ropidoxuridine may help whole brain radiation therapy work better by making cancer cells more sensitive to the radiation therapy.
Who can participate?
Inclusion Criteria:

- Patients must have histologically confirmed malignancy with brain metastases and are being evaluated for palliative WBRT

- Patients must not have received systemic cytotoxic chemotherapy or immunotherapy for 3 weeks before initiation of therapy; for oral targeted agents at least 4 half-lives of the agent should have elapsed prior to initiation of study therapy; prior hormonal therapy is permitted with no minimum interval to initiation of study therapy

- Eastern Cooperative Oncology Group (ECOG) performance status == 60%)

- Life expectancy of greater than 2 months

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,000/mcL

- Platelets >= 100,000/mcL

- Calculated creatinine clearance >= 45 mL/min/1.73 m^2

- Patients with Child-Pugh class A or B are eligible for the study

- Human immunodeficiency virus (HIV) positive (+) patients with CD4 counts >= 250 cells/mm^3 on anti-viral therapy are eligible for the study

- Negative serum pregnancy test result for females of child bearing potential; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of IPdR administration

- Ability to understand and the willingness to sign a written informed consent document


Exclusion Criteria:

- Patients must not have received prior cranial radiation therapy

- Patients with primary tumors including small cell carcinoma, neuroendocrine carcinoma, germ cell tumor, or lymphoma/leukemia

- Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

- Planned surgical resection and/or radiosurgery boost for any brain metastasis after WBRT

- Patients who are receiving any other investigational agent

- Patients with Child-Pugh class C cirrhosis

- Presence of leptomeningeal metastases; focal leptomeningeal enhancement on magnetic resonance imaging (MRI) without evidence of diffuse leptomeningeal disease is allowed

- History of allergic reactions attributed to compounds of similar chemical or biologic composition to IPdR

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IPdR
Resources
Location
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Contact
Steffany Lim
Research Topic
Conditions:
  • Metastatic Malignant Neoplasm
  • Metastatic Malignant Neoplasm in the Brain

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