Clinical Trial Details
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NCT02993146 : Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

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

- Life expectancy of greater than 2 months to allow completion of study treatment and
assessment of dose-limiting toxicity

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

- Leukocytes >= 3,000/mcL

- Absolute neutrophil count >= 1,000/mcL

- Platelets >= 100,000/mcL

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

- Total bilirubin:

- If no known liver metastases: total bilirubin < 1.5 x institutional upper limit
of normal (ULN)

- If known liver metastases, then: total bilirubin < 2.5 x ULN

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and
alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]):

- If no known liver metastases: AST/SGOT and ALT/SGPT both < 2 x ULN

- If known liver metastases, then: AST/SGOT and ALT/SGPT both < 5 x ULN

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

- Negative urine or serum pregnancy test result for females of child bearing potential
only; 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

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

Exclusion Criteria:

- Presence of diffuse lepto or pachy meningeal carcinomatosis (focal/localized
involvement from limited meningeal based metastases acceptable), greater than 1 cm
mid-line shift, uncal herniation, or severe hemorrhage/hydrocephalous (small
intra-lesional hemorrhage or anticipated surgical cavity is acceptable); patients with
seizure at presentation who have been started on levetiracetam and have been stable
for 48 hours prior to study registration are eligible at the discretion of treating

- Patients who have received systemic cytotoxic chemotherapy or approved oral targeted
therapy or immunotherapy for 2 weeks, or other investigational agents for 3 weeks (4
half-lives for any oral targeted agents), or radiotherapy to a non-brain site for 2
weeks before initiation of IPdR therapy; patients who have recovered from serious
(Common Terminology Criteria for Adverse Events [CTCAE] grade 3 or more higher) to
grade 1 or less adverse events from the previous therapies are eligible;
prior/current/future hormonal therapy and/or bisphosphonates are permitted with no
minimum interval to initiation of study therapy; if indicated, patients can receive
palliative radiation therapy to a non-brain site concurrent or immediately post-study
treatment with no minimum interval to initiation of study therapy

- Patients must not have received prior whole brain radiation therapy; previous SRS/SRT
done at least 3 weeks from the planned start of IPdR therapy is acceptable;
SRS/SRT/fractionated boosts or neurosurgery can be performed once the dose limiting
toxicity (DLT) assessment has been completed, if felt clinically necessary

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

- Patients who are receiving any other investigational agent

- Patients needing more than 8 mg dexamethasone per day at the time of start of WBRT
will not be eligible to participate in the study; however, patients will be allowed
entry into the study if it is medically safe to reduce the daily dose of dexamethasone
to 8 mg or less from the day of the start of WBRT; the dexamethasone dose for such
patients may be increased beyond 8 mg per day during the course of treatment if
medically necessary; this increased need for dose should be communicated to the
study's principal investigator, Dr Mohindra at the University of Maryland

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

- Uncontrolled intercurrent illness if it would increase the risk of toxicity or limit
compliance with study requirements; this includes, but is not limited to, ongoing
uncontrolled serious infection requiring intravenous (i.v.) antibiotics, progressive
congestive heart failure, unstable angina pectoris, 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
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