AN INTERNATIONAL, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF RINDOPEPIMUTC/GM-CSF WITH ADJUVANT TEMOZOLOMIDE IN PATIENTS WITH NEWLY DIAGNOSED, SURGICALLY RESECTED, EGFRVIII-POSITIVE GLIOBLASTOMA

Not Applicable

• Registration Number: PER-049-12
• Lead Sponsor: Celldex Therapeutics, Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1) HISTOLOGICALLY CONFIRMED, NEWLY DIAGNOSED, DE NOVO GLIOBLASTOMA INCLUDING THE FOLLOWING RECOGNIZED VARIANTS OF GLIOBLASTOMA: SMALL CELL GLIOBLASTOMA, GIANT CELL GLIOBLASTOMA, GLIOSARCOMA AND GLIOBLASTOMA WITH OLIGODENDROGLIAL COMPONENT (CENTRAL PATHOLOGIC REVIEW WILL BE PERFORMED AND HISTOLOGIC CONFIRMATION WILL BE REQUIRED PRIOR TO STUDY ENTRY).
2) ATTEMPTED SURGICAL RESECTION FOLLOWED BY CONVENTIONAL CHEMORADIATION, CONSISTING OF RADIOTHERAPY AT A MINIMALLY ACCEPTABLE TOTAL DOSE OF AT LEAST 90% OF THE PLANNED DOSE (APPROXIMATELY 60 GY) OF ABSORBED RADIATION, CONCURRENT WITH TEMOZOLOMIDE AT A TARGETED DOSE OF 75 MG/M2 BODY SURFACE AREA PER DAY. PATIENTS WHO RECEIVED AN INCOMPLETE COURSE OFTEMOZOLOMIDE MAY BE ELIGIBLE, PROVIDED INCLUSION CRITERION 7 IS MET.
3) TUMOR TISSUE SPECIMENS (PARAFFIN-EMBEDDED) FROM SURGICAL RESECTION MUST BE AVAILABLE FOR CENTRAL PATHOLOGY REVIEW, MGMT STATUS DETERMINATION AND ANALYSIS OF EGFRVIII STATUS.
4) DOCUMENTED EGFRVIII POSITIVE TUMOR STATUS, DETERMINED BY POLYMERASE CHAIN REACTION (PCR) ASSAY ON TUMOR TISSUE, PERFORMED AT A SPONSOR-DESIGNATED CENTRAL LABORATORY .

Exclusion Criteria

1) STEREOTACTIC BIOPSY ONLY (WITHOUT FURTHER SURGICAL RESECTION)
2) PRESENCE OF DIFFUSE LEPTOMENINGEAL DISEASE OR GLIOMATOSIS CEREBRI
3) HISTORY, PRESENCE, OR SUSPICION OF METASTATIC DISEASE
4) PATIENTS WHO HAVE RECEIVED ANY ADDITIONAL TREATMENT FOR GLIOBLASTOMA, ASIDE FROM SURGICAL RESECTION AND CHEMORADIATION WITH TEMOZOLOMIDE. AGENTS USED FOR DIAGNOSIS, IMAGING OR VISUALIZATION, EVEN IF INVESTIGATIONAL, ARE NOT EXCLUSIONARY. EXCLUSIONARY TREATMENTS WOULD INCLUDE, BUT ARE NOT LIMITED TO: STEREOTACTIC RADIOSURGERY, PLACEMENT OF GLIADEL® (CARMUSTINE; BCNU) WAFERS, ANY OTHER ANY OTHER INTRATUMORAL OR INTRACAVITY TREATMENT, RECEIPT OF OTHER CHEMOTHERAPIES, BEVACIZUMAB, OR INVESTIGATIONAL AGENTS.
5) ACTIVE SYSTEMIC INFECTION REQUIRING TREATMENT. A PATIENT WITH AN INFECTION CONTROLLED BY THERAPY WILL NOT BE EXCLUDED PROVIDED IT IS NOT CONSISTENT WITH EXCLUSION CRITERION 7.
6) HISTORY OF ANY MALIGNANCY (OTHER THAN GLIOBLASTOMA) DURING THE LAST THREE YEARS EXCEPT NON-MELANOMA SKIN CANCER, IN SITU CERVICAL CANCER, TREATED SUPERFICIAL BLADDER CANCER OR CURED, EARLY-STAGE PROSTATE CANCER IN A PATIENT WITH PSA LEVEL LESS THAN ULN.

Study & Design

• Study Type: Interventional
• Study Design: Not specified