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Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study

Phase 1/Phase 2
18 Years
Not Enrolling
Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma, Mixed Oligoastrocytoma

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Trial Information

Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study


I. Determine the toxicities and maximum tolerated dose of IL13-PE38QQR delivered by
continuous infusion into malignant glioma over 96 hours, in two courses eight weeks apart.

II. Estimate the response rate, response duration, time to response, and survival after
interstitial infusion of IL13-PE38QQR into recurrent malignant glioma.

III. Describe the toxicities of interstitial infusion of IL13-PE38QQR at the selected dose.

PROTOCOL OUTLINE: Patients are expected to receive two IL13-PE38QQR infusions at 8-week
intervals. For each course, drug will be infused through each of two catheters; infusion
rate will be held constant during a 96-hour infusion.

In Phase I, the dose of IL13-PE38QQR will be increased by increasing the IL13-PE38QQR
concentration in stepwise fashion, while holding infusion volume and duration constant.
Three patients will be treated at each dose level until the maximum tolerated dose (MTD) is
reached, and an additional three patients are treated at that level. In Phase II, patients
will be treated at the selected MTD.

PROJECTED ACCRUAL: In Phase I, up to 30 patients will be treated. In Phase II, up to 35
patients will be treated.

Inclusion Criteria

Disease Characteristics

- Must have had surgery (or biopsy) of a supratentorial brain tumor with pathologic
diagnosis of malignant (grade 3 or 4) glioma, including anaplastic astrocytoma,
glioblastoma multiforme and malignant mixed oligoastrocytoma. (Note: If diagnosis is
dependent upon the Day 0 biopsy, pathology must be confirmed prior to start of
IL13PE-38QQR infusion).

- Must have received cranial radiotherapy, with tumor dose of at least 48 Gy, completed
at least 12 weeks prior to study entry.

- Must have radiographic evidence of recurrent or progressive supratentorial tumor
compared with a previous study. The baseline tumor measurements must be determined
within 2 weeks prior to study entry. The tumor must have a solid portion at least 1.0
cm but not more than 5.0 cm in maximum diameter. A maximum of one satellite lesion is
permitted, if separated by less than 3 cm from the primary mass.

- Stereotaxic biopsy at study entry must confirm the presence of glioma.

Patient Characteristics

- Age 18 or greater.

- Karnofsky Performance Score must be at least 60.

- Hematologic status: Absolute neutrophils at least 1,500/mm^3; Hemoglobin at least 10
gm/dL; Platelets at least 100,000/mm^3; PT & PTT less than or equal to the upper
limit of normal.

- Hepatic Status: Transaminases not more than 2.5 x upper limit of normal; Total
Bilirubin not more than 2.0 mg/dL.

- Must have recovered from toxicity of prior therapy; at least 6 weeks elapsed since
receiving nitrosourea-containing chemotherapy and 3 weeks since receiving any other

- Must practice an effective method of birth control during the study.

- Must understand the investigational nature of this study and its potential risks and
benefits, and must sign informed consent.

- No patients with more than two foci of tumor, tumor crossing the midline, or
leptomeningeal tumor dissemination.

- No patients with impending herniation, spinal cord compression, or uncontrolled

- No patients who have received any localized antitumor therapy for the malignant
glioma, either intralesional chemotherapy or focal radiotherapy (i.e. any form of
stereotaxic RT or brachytherapy).

- No patients who are receiving concurrent chemotherapy or another investigational

- No patients with prior or concurrent malignancy. (Patients with curatively treated
carcinoma-in-situ or basal cell skin carcinoma OR who have been free of disease for
at least 5 years are eligible).

- Female patients must not be pregnant or breast-feeding.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jon Weingart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Johns Hopkins University


United States: Food and Drug Administration

Study ID:




Start Date:

November 2000

Completion Date:

July 2007

Related Keywords:

  • Malignant Glioma
  • Glioblastoma Multiforme
  • Anaplastic Astrocytoma
  • Mixed Oligoastrocytoma
  • neurosurgery, craniotomy
  • convection-enhanced delivery
  • CNS interstitial infusion
  • recombinant toxins
  • malignant glioma, recurrent
  • catheter, stereotaxic
  • intratumoral therapy
  • positive pressure microinfusion
  • Astrocytoma
  • Glioblastoma
  • Glioma
  • Oligodendroglioma



Wake Forest University Winston-Salem, North Carolina  27103
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
University of Pennsylvania Philadelphia, Pennsylvania  19104
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Emory University Atlanta, Georgia  30322
The Johns Hopkins University Baltimore, Maryland  21287
Henry Ford Health Systems Detroit, Michigan  48202
Cleveland Clinic Cleveland, Ohio  44195