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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ronald E. Warnick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barrett Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067001

NCT ID:

NCT00003842

Start Date:

March 1999

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Astrocytoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
John Wayne Cancer InstituteSanta Monica, California  90404
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Laboratory of Molecular BiologyBethesda, Maryland  20892
University of Southern California, Healthcare Consultation CenterLos Angeles, California  90033
Neuro-Oncology ServiceSan Francisco, California  94143-0372
Food and Drug AdministrationRockville, Maryland  20857
Charlotte Neurosurgical AssociatesCharlotte, North Carolina  28207-1830