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Clinical Trials/EUCTR2013-005387-25-IT
EUCTR2013-005387-25-IT
Active, not recruiting
Phase 1

Phase 2a Study of an Immunotherapeutic Vaccine, DPX-Survivac, Alone or with Low dose Cyclophosphamide in Primary Glioblastoma Patients Receiving Standard of Care Therapy

Sapienza, University of Rome0 sites10 target enrollmentJanuary 7, 2014
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ConditionsGlioblastoma is the most common primary brain tumour in humans withthe most severe prognosis. Standard treatments consist primarily ofsurgery in order to debulk thetumoral mass, as well asradiochemotherapy to induce optimal local tumor control. However themedian overall survival (OS)is about 15 months, with 88% of patientsdead within 3 yearsMedDRA version: 18.0Level: HLTClassification code 10045172Term: Tumour vaccine therapiesSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Cancer [C04]
DrugsDPX-SURVIVAC

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Glioblastoma is the most common primary brain tumour in humans withthe most severe prognosis. Standard treatments consist primarily ofsurgery in order to debulk thetumoral mass, as well asradiochemotherapy to induce optimal local tumor control. However themedian overall survival (OS)is about 15 months, with 88% of patientsdead within 3 years
Sponsor
Sapienza, University of Rome
Enrollment
10
Status
Active, not recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 7, 2014
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Primary or recurrent histologically confirmed GBM after surgery
  • •2\.Total or subtotal (at least 90%) resection of tumour mass, confirmed by assessment of neurosurgeon and postoperative magnetic resonance imaging (MRI) within 48 hours
  • •3\.Ages 18 to 70 years old
  • •4\.Postoperative Karnofsky Performance Status (KPS) \=70
  • •5\.A life expectancy \> 6 months
  • •6\.Adequate hematologic, renal and hepatic function
  • •7\.Fertile subjects must use acceptable birth control from screening until the last study visit or early termination. Acceptable methods of birth control include: spermicide with condom, diaphragm, or cervical cap, IUD (intrauterine device), hormonal contraception, vasectomy, and abstinence. (Plan B or the rhythm method are not considered reliable methods.)
  • •8\.Willing and able to provide written informed
  • •9\.Ability to comply with protocol requirements
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •1\.Past or ongoing documented autoimmune diseases
  • •2\.HIV, syphilis, active HBV and HCV infection
  • •3\.Any medical disorder that would impair the ability to receive study treatment
  • •4\.Other active of in the past five years malignancies
  • •5\.Any unresolved chronic toxicity greater than Grade 2 (NCI\-CTCAE version 4\.03\) from previous anticancer therapy (except alopecia)
  • •6\.Pregnant or breast feeding patients
  • •7\.Documented immune deficiency
  • •8\.Lymphodemia in the region to be vaccinated
  • •9\. Mandatory treatment with corticosteroids or salicylates in inflammatory dose

Outcomes

Primary Outcomes

Not specified

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