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Intracerebral Convection Enhanced Delivery of Carboplatin for Treatment of Recurrent High-grade Gliomas

Phase 1
18 Years
70 Years
Open (Enrolling)
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Recurrent Adult Brain Tumor

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Trial Information

Intracerebral Convection Enhanced Delivery of Carboplatin for Treatment of Recurrent High-grade Gliomas


I. Establish the maximum tolerated dose and define the toxicity profile of carboplatin
delivered intracerebrally via convection enhanced delivery (CED) for patients with high
grade glial neoplasms.


I. Examine the efficacy as defined by six-month progression free survival (PFS), median
progression free survival, overall survival, and the radiographic response rate.

II. Evaluate the drug distribution.

OUTLINE: This is a phase I, dose-escalation study.

Patients undergo craniotomy and then receive carboplatin intracerebrally via
convection-enhanced delivery (CED) over 72 hours.

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

- 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

- 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

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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish maximum tolerated dose and define toxicity profile

Outcome Description:

The toxicity profile of carboplatin delivered intracerebrally via convection enhanced delivery (CED) for patients with high grade glial neoplasms. The maximum tolerated dose (MTD) of infused carboplatin may then be incorporated into future clinical studies.

Outcome Time Frame:

72 hours after maximal medical therapy is initiated

Safety Issue:


Principal Investigator

James Elder

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

Related Keywords:

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Oligodendroglioma
  • Recurrent Adult Brain Tumor
  • Astrocytoma
  • Brain Neoplasms
  • Oligodendroglioma



Ohio State University Medical Center Columbus, Ohio  43210