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.]

NCT01644955 : Carboplatin in Treating Patients With Recurrent High-Grade Gliomas
PhasePhase 1
AgesMin: 18 Years Max: 70 Years
Eligibility
Inclusion Criteria:

- Patients must have progressive disease for which craniotomy and tumor resection is
recommended as treatment

- Patients must sign a consent form indicating that they are aware of the
investigational nature of the study; the informed consent form will indicate that the
patient has been made aware of all other appropriate therapies

- Patients with histologically confirmed grade III or IV astrocytoma, oligoastrocytoma,
and oligodendroglioma who are at first or second recurrence

- Patients require an initial diagnosis of a malignant glioma as outlined in the
inclusion criteria which must be confirmed at the treating facility

- Patients must have unequivocal evidence of tumor progression by magnetic resonance
imaging (MRI) performed no longer than 28 days prior to study registration

- Patients must have pathologically confirmed recurrence at the time of catheter
placement

- Patients must be on a stable or decreasing dexamethasone dosage for at least 1 week
prior to baseline MRI

- Patients must have been treated previously with radiation therapy and treatment must
have been completed at least 8 weeks prior to surgery for catheter implantation

- Last dose of cytotoxic chemotherapy must have been at least 4 weeks (6 weeks for
nitrosoureas) prior to catheter placement; patients are eligible if they received
bevacizumab or other anti-vascular endothelial growth factor (VEGF) therapies,
although the most recent dose must be at least 6 weeks prior to catheter placement

- Patients previously treated with stereotactic radiosurgery, stereotactic radiotherapy,
brachytherapy, Gliadel wafers or other intratumoral chemotherapy are eligible

- Patients must have recovered from all prior therapy

- Patients must have a life expectancy of >= 3 months and a Karnofsky performance status
>= 60 Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Platelets >=
100,000/mcL Hemoglobin >= 9 g/dL Serum calcium =< 12.0 mg/dL Total serum bilirubin <
institutional upper limit of normal (ULN) Aspartate aminotransferase (AST)(serum
glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum
glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN Creatinine < 1.5 X
institutional ULN

- Women of child bearing years must have a negative pregnancy test (serum or urine)
within 1 week of study entry; men and women of reproductive potential must agree to
use an effective contraceptive method including one of the following: surgical
sterilization (tubal ligation for women or vasectomy for men); approved hormonal
contraceptives (such as birth control pills, Depo-Provera or Lupron Depro); barrier
methods (such as condom or diaphragm) used with a spermicide cream or an intrauterine
device (IUD)

- Patient or designated individuals with durable medical power of attorney must give
written informed consent prior to any study-specific procedures being implemented

- Both men and women and members of all races and ethnic groups are eligible for this
trial

Exclusion Criteria:

- Patients with infratentorial, multifocal, or pathologically confirmed cerebrospinal
fluid (CSF) disseminated tumor

- Patients that have been treated with > 3 prior chemotherapy regimens

- Pregnant or lactating women or women of childbearing potential and men who are
sexually active and not willing/able to use medically acceptable forms of
contraception

- Patients who have a history of bleeding disorders including congenital or acquired
coagulopathies

- Known acquired immune deficiency syndrome (AIDS) based upon current Centers for
Disease Control and Prevention (CDC) definition or other acquired or congenital
disorder of the immune system

- Patients with unstable or serious concurrent illness including, but not limited to,
ongoing or active infections requiring IV antibiotics or psychiatric illness/social
situations that would limit compliance with study requirements are ineligible; (if
patient has a stable chronic infection requiring oral antibiotics, the patient may be
treated at the investigators discretion; however a clinical note must include the
justification regarding the safety of treating the patient)

- Patients who have received any other investigational agent in a 28-day period prior to
enrollment in this study

- Patients whose tumors are located less than 2 cm from the ventricles

- Patients taking greater than 12 mg daily of dexamethasone

- Prior invasive malignancy that is not low-grade glioma, glioblastoma or gliosarcoma
(except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the
patient has been disease free and off therapy for that disease for a minimum of 3
years
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01644955      |      Link to official Clinicaltrials.gov listing
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