Immunotoxin Therapy in Treating Patients With Malignant Glioma - Full Text View

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006268

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Biological: cintredekin besudotox Drug: isolated perfusion Procedure: conventional surgery	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cintredekin Besudotox

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006268

Locations

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

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Jon Weingart, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068211, NABTT-9903, JHOC-NABTT-9903, NEOPHARM-TS-G1-TI4, NEOPHARM-IL13PEI-001-R03
Study First Received:	September 11, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00006268 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma

adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Central Nervous System Neoplasms
Recurrence
Immunotoxins
Brain Neoplasms
Neuroectodermal Tumors

Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Gliosarcoma
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Nervous System Diseases

Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009