IL-4(38-37)-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 1999 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003842
First received: November 1, 1999
Last updated: December 17, 2013
Last verified: June 1999
  Purpose

RATIONALE: IL-4(38-37)-PE38KDEL immunotoxin may locate tumor cells and kill them without harming normal cells. This may be an effective treatment for recurrent malignant astrocytoma.

PURPOSE: Phase I trial to study the effectiveness of IL-4(38-37)-PE38KDEL immunotoxin in treating patients who have recurrent malignant astrocytoma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: interleukin-4 PE38KDEL cytotoxin
Drug: isolated perfusion
Procedure: surgical procedure
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of a Recombinant Chimeric Protein Composed of Circularly Permuted IL-4 and a Mutated Form of the Pseudomonas Exotoxin Termed IL-4(38-37)-PE38KDEL (IL-4 Toxin) for the Treatment of Recurrent Malignant Astrocytoma

Resource links provided by NLM:


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

Estimated Enrollment: 30
Study Start Date: March 1999
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of intratumorally infused IL-4(38-37)-PE38KDEL immunotoxin in patients with recurrent malignant astrocytoma. II. Determine the safety of this regimen in these patients. III. Determine preliminarily any efficacy of this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients undergo a stereotactic biopsy under MR/CT guidance. Catheters are then placed into the tumor under stereotactic guidance. The catheter is filled with IL-4(38-37)-PE38KDEL immunotoxin (IL-4 toxin), with infusion beginning 24 hours after catheter insertion. The IL-4 toxin is infused over 4 days. The catheter is removed 45 minutes after the infusion is completed and a MR scan is performed. Cohorts of 3 patients each receive escalating doses of IL-4 toxin until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding the dose at which 2 of 3 patients experience dose limiting toxicity. Patients are followed every 4 weeks for 16 weeks, then every 8 weeks for up to 3 years.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS: Histologically proven recurrent glioblastoma or anaplastic astrocytoma Stereotactically accessible, enhancing mass no greater than 50 mL total volume by MRI No significant mass effect Recent craniotomy allowed No anaplastic oligodendroglioma No tumors of the brainstem, cerebellum, or both hemispheres No diffuse subependymal or CSF disease If on stable or increasing dose of steroid, must have evidence of increasing contrast enhancement by MRI or CT scan Prior external beam radiotherapy required

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9.5 g/dL Hepatic: Bilirubin less than 2 mg/dL AST and ALT less than 2 times upper limit of normal (ULN) PT/PTT no greater than ULN Renal: Creatinine less than 2 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No systemic diseases to cause unacceptable anesthetic/operative risk No active infection requiring treatment No unexplained febrile illness

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent blood or platelet transfusions Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Medically able to undergo surgery Other: No other concurrent investigational agents

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003842

Locations
United States, California
University of Southern California, Healthcare Consultation Center
Los Angeles, California, United States, 90033
Neuro-Oncology Service
San Francisco, California, United States, 94143-0372
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
United States, Maryland
Laboratory of Molecular Biology
Bethesda, Maryland, United States, 20892
Food and Drug Administration
Rockville, Maryland, United States, 20857
United States, Missouri
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
United States, North Carolina
Charlotte Neurosurgical Associates
Charlotte, North Carolina, United States, 28207-1830
United States, Ohio
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Barrett Cancer Center
Investigators
Study Chair: Ronald E. Warnick, MD Barrett Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003842     History of Changes
Other Study ID Numbers: CDR0000067001, UCMC-981061, NBI-3001-9802, NCI-V99-1536
Study First Received: November 1, 1999
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Astrocytoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Interleukin-4
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 19, 2014