Isolated perfusion and cintredekin besudotox and conventional surgery in Brain and Central Nervous System Tumors - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Brain and Central Nervous System Tumors

Intervention / Treatment

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.

Study Type

Interventional

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35294-3300
    - University of Alabama at Birmingham Comprehensive Cancer Center
- Florida
  - Tampa, Florida, United States, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Winship Cancer Institute of Emory University
- Maryland
  - Baltimore, Maryland, United States, 21231-2410
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  - Bethesda, Maryland, United States, 20892-1182
    - Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  - Bethesda, Maryland, United States, 20892-1414
    - National Institute of Neurological Disorders and Stroke
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital Cancer Center
- Michigan
  - Detroit, Michigan, United States, 48202
    - Josephine Ford Cancer Center at Henry Ford Health System
- North Carolina
  - Winston-Salem, North Carolina, United States, 27157-1082
    - Comprehensive Cancer Center at Wake Forest University
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104-4283
    - Abramson Cancer Center at the University of Pennsylvania
- Texas
  - San Antonio, Texas, United States, 78284-7811
    - University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New Approaches to Brain Tumor Therapy Consortium

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Study Completion (ACTUAL)

March 1, 2005

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified