Pure Global

Vaccine Therapy, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme - Trial NCT01222221

Access comprehensive clinical trial information for NCT01222221 through Pure Global AI's free database. This Phase 1 trial is sponsored by Cancer Research UK and is currently Completed. The study focuses on Brain and Central Nervous System Tumors. Target enrollment is 45 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT01222221
Phase 1
Completed
biological
Trial Details
ClinicalTrials.gov โ€ข NCT01222221
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Vaccine Therapy, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
A Cancer Research UK Phase I Trial of IMA950 (A Novel Multi-Peptide Vaccine) Plus GM-CSF in Patients With Newly Diagnosed Glioblastoma

Study Focus

glioblastoma multiforme multipeptide vaccine IMA950

Interventional

biological

Sponsor & Location

Cancer Research UK

Cambridge,London,Southampton,Glasgow,Edinburgh,Leeds,Manchester, United Kingdom

Timeline & Enrollment

Phase 1

Jul 01, 2010

Feb 01, 2015

45 participants

Primary Outcome

Causality of each adverse event (AE) to glioblastoma multiform multi-antigen vaccine IMA950 and GM-CSF and AE severity according to NCI CTCAE Version 4.0,Total number of patients showing patient-individual T-cell responses against a single or multiple tumor-associated peptides (TUMAP) contained in the study vaccine IMA950 at one or more post-vaccination time points by HLA multimer analysis

Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response
 to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways
 to stop the growth of tumor cells, either by killing the cells or by stopping them from
 dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving vaccine
 therapy together with temozolomide and radiation therapy may kill more tumor cells.
 
 PURPOSE: This phase I trial is studying the side effects of vaccine therapy when given
 together with temozolomide and radiation therapy in treating patients with newly diagnosed
 glioblastoma multiforme.

ICD-10 Classifications

Malignant neoplasm: Overlapping lesion of brain and other parts of central nervous system
Malignant neoplasm: Central nervous system, unspecified
Benign neoplasm of brain and other parts of central nervous system
Malignant neoplasm of brain
Secondary malignant neoplasm of other and unspecified parts of nervous system

Data Source

ClinicalTrials.gov

NCT01222221

Non-Device Trial