Clinical Trial Details
Braintumor Website

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NCT01156584 : A Study of a Retroviral Replicating Vector Administered to Subjects With Recurrent Malignant Glioma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- at least 18 years of age

- for intratumoral cohorts, supratentorial HGG (WHO grade III or IV)

- technically unresectable HGG

- initial definitive therapy such as surgery with or without adjuvant radiation

- subject elected not to undergo treatment with Gliadel wafer

- if receiving corticosteroids, dose is stable or decreasing for past 7 days

- KPS: at least 70

- absolute neutrophil count > 1500/mm^3

- absolute lymphocyte count > 500/mm^3

- platelet count > 100,000/mm^3

- hemoglobin > 10 g/dL

- for intratumoral cohort, coagulation profile favorable to surgery

- estimated glomerular filtration rate > 50 mL/min

- ALT < 3 times ULN and bilirubin < 1.5 mg/dL

- negative serum pregnancy test

Exclusion Criteria:

- cytotoxic therapy within the past 4 weeks (6 weeks for BCNU/CCNU)

- more than 2 recurrences including present recurrence

- Gliadel wafer or wafers implanted within the past 8 weeks

- taking more than 8 mg of dexamethasone per day

- for intratumoral cohorts, injection of tumor would require violation of ventricular

- any infection requiring antibiotic, anticoagulant, or antiplatelet agents within the
past 4 weeks

- for intratumoral cohort, bleeding diathesis or use of anticoagulants/antiplatelet
agents that cannot be stopped

- allergy or intolerance to 5-FC

- HIV positive

- g.i. condition that would prevent ingestion or absorption of 5-FC

- any investigational treatment within the past 30 days

- pregnant or breast feeding

- received Avastin

- history of prior malignancy, excluding basal or squamous cell carcinoma of the skin,
with an expected survival of less than 5 years.
LinksPermanent Link to THIS page:      |      Link to official listing
Duarte, California
Facility: City of Hope
Investigator: Jana Portnow, MD
Contact: Claudia Aceves, CCRC Phone: 626-256-4673
Click HERE to send email to this center

Los Angeles, California
Facility: UCLA
Investigator: Tim Cloughesy, MD
Contact: Tim Cloughesy, MD Phone: 310-825-5321
Click HERE to send email to this center

San Diego, California
Facility: UCSD
Investigator: David Piccioni, MD
Contact: Lara Rose Phone: 858-822-6575
Click HERE to send email to this center

San Francisco, California
Facility: UCSF
Investigator: Manish Aghi, MD
Contact: Thelma Munoz Phone: 415-353-2523
Click HERE to send email to this center

Detroit, Michigan
Facility: Henry Ford Hospital
Investigator: Tobias Walbert, MD
Contact: John Gaggin, RN, BSN Phone: 313-916-3731
Click HERE to send email to this center

Hackensack, New Jersey
Facility: Hackensack University Medical Center
Investigator: George Kaptain, MD, FACS
Contact: Lori Cappello, RN, BSN Phone: 551-996-5098
Click HERE to send email to this center

Cleveland, Ohio
Facility: Cleveland Clinic Foundation
Investigator: Michael Vogelbaum, MD
Contact: Cathy Brewer, RN Phone: 216-444-7937
Click HERE to send email to this center

Columbus, Ohio
Facility: The Ohio State University
Investigator: James B Elder, MD
Contact: Christopher Rond, MSN, RN Phone: 614-293-6563
Click HERE to send email to this center

Pittsburgh, Pennsylvania
Facility: University of Pittsburgh Medical Center
Investigator: Johnathan A. Engh, MD
Contact: Melinda Vargas-Jaffe, RN Phone: 412-235-1320
Click HERE to send email to this center

Houston, Texas
Facility: The Methodist Hospital Research Institute
Investigator: David Baskin, MD
Contact: Lenis Sosa, MSN, RN Phone: 713-441-3245
Click HERE to send email to this center

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