Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

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

- Patients must have histologically confirmed malignancy with brain metastases and are
being evaluated for 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 < 2 x ULN

- If known liver metastases, then: AST/SGOT < 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
administration

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

Exclusion Criteria:

- Patients with 1-3 brain metastases, each < 3 cm by contrast magnetic resonance imaging
(MRI), with stable systemic disease and ECOG score of 0-2, who would otherwise be
eligible for stereotactic radiosurgery (SRS)/stereotactic radiation therapy (SRT)
alone should not be enrolled into this study unless WBRT is recommended due to any
medical reasons or logistic limitations as determined by the treating physician;
patients who develop recurrence post-SRS/SRT or surgery alone and are recommended WBRT
will be eligible for the protocol

- Presence of diffuse leptomeningeal carcinomatosis (focal/localized involvement is
acceptable), greater than 1 cm mid-line shift, uncal herniation, or significant
hemorrhage/hydrocephalous (small intra-lesional hemorrhage 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 physician

- Patients who have received systemic cytotoxic chemotherapy or immunotherapy for 3
weeks before initiation of IPdR therapy or patients who have not recovered from
serious (Common Terminology Criteria for Adverse Events [CTCAE] grade 3 or more)
adverse events from the previously received agents; 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

- Patients must not have received prior whole brain radiation therapy; (previous SRS/SRT
done at least 4 weeks from the planned start of IPdR therapy is acceptable); patients
planned upfront to undergo SRS/SRT/fractionated boosts or neurosurgery after WBRT are
not eligible, however, these treatments/procedures 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 that 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, 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
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02993146      |      Link to official Clinicaltrials.gov listing
Locations
La Jolla, California
Facility: UC San Diego Moores Cancer Center
Investigator: David E. Piccioni
Contact: David E. Piccioni Phone: 858-822-5354
Click HERE to send email to this center

Sacramento, California
Facility: University of California Davis Comprehensive Cancer Center
Investigator: Karen L. Kelly
Contact: Karen L. Kelly Phone: 916-734-3089
Email not avaialable

Baltimore, Maryland
Facility: University of Maryland/Greenebaum Cancer Center
Investigator: Pranshu Mohindra
Contact: Pranshu Mohindra Phone: 800-888-8823
Email not avaialable

Rochester, Minnesota
Facility: Mayo Clinic Cancer Center LAO
Investigator: Pranshu Mohindra
Contact: Pranshu Mohindra
Click HERE to send email to this center

New York, New York
Facility: Columbia University/Herbert Irving Cancer Center
Investigator: Mary R. Welch
Contact: Mary R. Welch Phone: 212-305-8615
Email not avaialable




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