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A Phase 2a Study of AdV-tk + Valacyclovir Gene Therapy in Combination With Standard Radiation Therapy for Malignant Glioma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma

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Trial Information

A Phase 2a Study of AdV-tk + Valacyclovir Gene Therapy in Combination With Standard Radiation Therapy for Malignant Glioma


Up-front patients must have resectable or partially resectable malignant glioma and receive
injection of AdV-tk into remaining tumor or tumor bed after resection. Pathologic
confirmation of malignant glioma must be made prior to AdV-tk injection; if this is not
possible, the injection will not be performed and the subject will no longer be eligible for
the study.

Patients who have previously received AdV-tk + prodrug on this study may receive an
additional AdV-tk + prodrug course at recurrence if eligibility criteria are still met.

The dose level of AdV-tk is 3x10e11 vector particles. The oral prodrug, valacyclovir, is
started 1-3 days after AdV-tk injection and continue for 14 days. Standard radiotherapy will
begin 3-7 days after AdV-tk injection for the up-front course. For the recurrent course, if
radiation is indicated, it will also begin 3-7 days after AdV-tk injection.

Patients may receive temozolomide as per standard of care after completion of prodrug. For
recurrent administration, standard of care chemotherapy may be administered after completion
of prodrug.


Inclusion Criteria:



- Must have presumed resectable or partially resectable malignant glioma based on
clinical and radiologic evaluation (pathologic confirmation of malignant glioma must
be made at the time of surgery if not previously determined). Patients who have
previously received AdV-tk + prodrug on this study may receive an additional AdV-tk +
prodrug course at recurrence if eligibility criteria are still met.

- Tumor must be accessible for injection and must not be located in the brainstem,
midbrain, contained within the ventricular system, or located in an infratentorial
location.

- Must be planning to undergo standard radiation therapy.

- Performance status KPS 70 or more.

- SGOT (AST) < 3x upper limit of normal.

- Serum creatinine < 2mg/dl and calculated creatinine clearance >10ml/min.

- Platelets > 100,000/mm3 and WBC > 3000/mm3.

- Patients of reproductive age must agree to use a medically accepted form of birth
control while on the study.

- Must give study specific informed consent prior to enrollment. For re-administration,
patients must be re-consented.

- Must be able to tolerate MRI scan procedure

Exclusion Criteria:

- Active liver disease including cirrhosis or hepatitis

- Patients on immunosuppressive drugs (with exception of corticosteroid)

- Known HIV+ patients.

- Acute infections (viral, bacterial or fungal infections requiring therapy).

- Pregnant or breast feeding patients. Female patients of childbearing age must have
negative serum or urine pregnancy test within 1 week of beginning therapy.

- Evidence of metastatic disease or other malignancy (except squamous or basal cell
skin cancers).

- Other serious co-morbid illness or compromised organ function.

- May not receive chemotherapy until valacyclovir completed

- May not receive other investigational anti-tumor agents within 30 days prior to study
entry or during active participation in the study (defined as from AdV-tk injection
until tumor progression).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Expand the safety evaluation at the maximum dose of AdV-tk evaluated in a completed phase Ib study

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

E. Antonio Chiocca, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

BrTK02

NCT ID:

NCT00589875

Start Date:

March 2007

Completion Date:

December 2013

Related Keywords:

  • Malignant Glioma
  • Glioblastoma Multiforme
  • Anaplastic Astrocytoma
  • Immunotherapy
  • Cytotoxicity
  • Tumor vaccine
  • Astrocytoma
  • Glioblastoma
  • Glioma

Name

Location

City of Hope Medical CenterDuarte, California  91010
The University of ChicagoChicago, Illinois  60637
The Ohio State University Medical Center, Dept. Neurological SurgeryColumbus, Ohio  43210
The Methodist Hospital Neurological InstituteHouston, Texas  77030