Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Immunotoxin Therapy in Treating Patients With Malignant Glioma

Basic Trial Information

Objectives

1. Determine the toxic effects and maximum tolerated dose (MTD) of interstitial interleukin-13 PE38QQR immunotoxin in patients with malignant glioma.
2. Determine the response rate, duration of response, time to response, overall survival, and time to progression in patients treated with this regimen.
3. Determine the toxic effects of this drug at the MTD in these patients.

Entry Criteria

Disease Characteristics:

• Histologically proven malignant glioma (grade 3 or 4)
  • Anaplastic astrocytoma
  • Glioblastoma multiforme
  • Malignant mixed oligoastrocytoma

• Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at least 12 weeks prior to study

• Must have undergone supratentorial brain tumor surgery or biopsy

• Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study
  • Must have solid portion measuring 1.0-5.0 cm in maximum diameter
  • Maximum of 1 satellite lesion allowed if separated from the primary mass by less than 3 cm
  • No tumor crossing the midline
  • No leptomeningeal tumor dissemination
  • No impending herniation or spinal cord compression

• No uncontrolled seizures

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior intralesional chemotherapy for malignant glioma
• At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas) and recovered
• No concurrent chemotherapy

Endocrine therapy:

• Concurrent corticosteroids allowed, but dose must remain stable or be tapered during study

Radiotherapy:

• See Disease Characteristics
• No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or brachytherapy) for malignant glioma

Surgery:

• See Disease Characteristics

Other:

• Recovered from any prior therapy
• No other concurrent investigational agent

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Hemoglobin at least 10 g/dL
• Platelet count at least 100,000/mm³

Hepatic:

• PT and PTT no greater than upper limit of normal (ULN)
• SGOT and SGPT no greater than 2.5 times ULN
• Bilirubin no greater than 2.0 mg/dL

Renal:

• Not specified

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer

Expected Enrollment

A maximum of 30 patients will be accrued for phase I of the study within 6 months and a total of 12-35 patients will be accrued for phase II of the study within 10-12 months.

Outline

This is a dose-escalation, multicenter study.

Patients undergo stereotactic biopsy of brain tumor followed by CT guided stereotactic placement of 2 intratumoral catheters on day 0. Patients with histologically confirmed malignant glioma receive interleukin-13 PE38QQR immunotoxin interstitially over 96 hours beginning on day 1. Patients with a residual enhancing mass undergo repeat catheter placement on day 56 and then receive a second interstitial infusion beginning on day 57 in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD.

Patients are followed every 8 weeks.

Trial Contact Information

Trial Lead Organizations

New Approaches to Brain Tumor Therapy

Jon Weingart, MD, Protocol chair		Ph: 410-614-3052

Registry Information
Official Title		Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study
Trial Start Date		2000-10-06
Registered in ClinicalTrials.gov		NCT00006268
Date Submitted to PDQ		2000-08-04
Information Last Verified		2005-03-10
NCI Grant/Contract Number		CA006973, CA062475

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