Studie IFN-Beta Gene Transfer

[Mike]

Phase 1 trial of IFN-Beta Gene Transfer in the Treatment of Glioblastoma Multiforme

Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Glioblastoma Multiforme

Phase: Phase 1

Age Group: Adults Only

Min Karnofsky Score: 70: Cares for self, unable to perform normal activity or to do active work

Conditions:
Prior Surgery is Allowed
Prior Radiation is Allowed
Prior Chemotherapy is Allowed

Tumor Types: Glioblastoma Multiforme

Treatment Type: Gene Therapy

Contact:
Stephen Eck MD, PhD
Principal Investigator
Hospital of the University of Pennsylvania
512 BRB II/III
421 Curie Boulevard
Philadelphia, PA 19104 USA
Phone: 215-662-6392
Fax: 215-349-5319
E-mail: arecio@mail.med.upenn.edu


STUDY SUMMARY:

This is a phase I clinical trial in patients with recurrent or progressive Glioblastoma Multiforme (GBM), in which resection is clinically indicated. In this study, an investigational replication-defective, recombinant adenovirus expressing the interferon-beta gene (BG00001) will be directly injected into the tumor and tumor bed, in order to deliver the hIFN-beta gene. The purpose of the study is to evaluate safety and any harmful effects of injection of BG00001. Also, this study will help determine whether the virus carrying the beta interferon gene will enter brain tumor cells and cause the cancer cells to die. This study will require two hospital admissions for the actual procedure of drug administration. All other visits will be conducted on an out-patient basis.



OVERVIEW OF TREATMENT INVOLVED:

Treatment for GBM in this study requires two injections of the investigational drug into the tumor and tumor bed. The first injection is an intracranial injection and will require a hospital stay of at least 5 days. Eight days following this initial injection, the tumor will be resected and study medication will be injected into the tumor bed.

This is a dose escalation study, so the actual dosage of drug a patient receives may vary depending on when a patient is enrolled.



ARE YOU ELIGIBLE TO ENTER?

In order to qualify for this study, you must meet the following criteria:

Must be greater than or equal to 18 years of age.
Must have histologically proven GBM and recurrent OR progressive tumor following prior treatment.
The tumor must be amenable to radical resection
Must have an ECOG performance status of 0-2
Must be on anticonvulsant therapy and must have therapeutic serum levels within 2 weeks prior to Day 1, if therapeutic levels are defined for the anticonvulsant being used.
Must give written informed consent.


WHAT COULD EXCLUDE YOU FROM THIS STUDY:

Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment:

Medical History
Any clinically significant, uncontrolled medical illness, as determined by the investigator.
Abnormal blood tests exceeding any of the limits defined below:
Alanine transaminase (ALT) > four times ( 4 ) the upper limit of normal (ULN).
Aspartate transaminase (AST) > 4 the ULN.
Total bilirubin >1.5 mg/dL.
Absolute neutrophil count <1,500 cells/mm3.
Platelet count <100,000 cells/mm3.
Serum creatinine >2 ULN.
Prothrombin time (PT) >2 seconds above the ULN.
Serum sodium (Na) <125 mEq/L or >150 mEq/L.
Serum potassium (K) <3.5 mEq/L or > 5.5 mEq/L.
Multi-centric tumor that can not be resected in a single, contiguous operative field.
Brainstem, or optic chiasm involvement of tumor.
The linear dimension of contact between gadolinium-enhancing tumor and a cerebral ventricle is greater than 1 cm.
Uncontrolled seizure disorder.

History of a new diagnosis or treatment of an invasive malignancy other than GBM within 5 years of enrollment. Curatively treated subjects with a history of basal cell or squamous cell carcinoma of the skin, superficial transitional cell carcinoma of the bladder, and non-invasive carcinoma of the uterine cervix are not excluded.
Treatment History

Treatment with radiation therapy, including interstitial radiation or radiosurgery, must be completed at least 8 weeks prior to Day 1.

Treatment with nitrosoureas must be completed at least 6 weeks prior to Day 1. Treatment with other chemotherapeutic agents must be completed at least 4 weeks prior to Day 1.

Treatment with any investigational drug or approved therapy for investigational use must be completed at least 4 weeks prior to Day 1.
History of intolerance to corticosteroids that would preclude use during this study, or history of any medical condition that precludes the use of corticosteroids.
Any prior treatment with a gene delivery vector, or an adenovirus therapeutic.


LOCATION AND CONTACT INFORMATION:
To find out more information about this study or how you can be screened, please contact Katie L. Walsh, Clinical Project Manager at 800-824-6436 x2670 or Jima H. Deyab, Clinical Project Coordinator at 800-824-6436 x3234. The sponsor company is Biogen, Inc.

Sites that are currently enrolling for this study:

Alabama
University of Alabama at Birmingham, Birmingham, Alabama
Jolene Lewis, RN: 205-975-0438
Steven S. Rosenfeld, MD, PhD, Principal Investigator
Arizona
University of Arizona, Health Sciences Center, Tucson, AZ
Dennis Way: 520-626-6731
Allan Hamilton, MD, Principal Investigator
Pennsylvania
University of Pennsylvania School of Medicine, Philadelphia, PA
Adri Recio, RN: 215-662-6392
Stephen L. Eck, MD, PhD, Principal Investigator