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Immunotoxin Therapy in Treating Patients With Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cintredekin besudotox
isolated perfusion
conventional surgery
Sponsored by
New Approaches to Brain Tumor Therapy Consortium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Hemoglobin at least 10 g/dL Platelet count at least 100,000/mm^3 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 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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  • Winship Cancer Institute of Emory University
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • National Institute of Neurological Disorders and Stroke
  • Massachusetts General Hospital Cancer Center
  • Josephine Ford Cancer Center at Henry Ford Health System
  • Comprehensive Cancer Center at Wake Forest University
  • Abramson Cancer Center at the University of Pennsylvania
  • University of Texas Health Science Center at San Antonio

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
June 20, 2013
Sponsor
New Approaches to Brain Tumor Therapy Consortium
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006268
Brief Title
Immunotoxin Therapy in Treating Patients With Malignant Glioma
Official Title
Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
New Approaches to Brain Tumor Therapy Consortium
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for malignant glioma. PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating patients who have malignant glioma.
Detailed Description
OBJECTIVES: Determine the toxic effects and maximum tolerated dose (MTD) of interstitial interleukin-13 PE38QQR immunotoxin in patients with malignant glioma. Determine the response rate, duration of response, time to response, overall survival, and time to progression in patients treated with this regimen. Determine the toxic effects of this drug at the MTD in these patients. 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. PROJECTED ACCRUAL: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
cintredekin besudotox
Intervention Type
Drug
Intervention Name(s)
isolated perfusion
Intervention Type
Procedure
Intervention Name(s)
conventional surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Hemoglobin at least 10 g/dL Platelet count at least 100,000/mm^3 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Weingart, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
National Institute of Neurological Disorders and Stroke
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1414
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Abramson Cancer Center at the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States

12. IPD Sharing Statement

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Immunotoxin Therapy in Treating Patients With Malignant Glioma

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