A Cancer Research UK Phase I Trial of IMA950 (A Novel Multi-Peptide Vaccine) Plus GM-CSF in Patients With Newly Diagnosed Glioblastoma

NCT01222221 Phase 1 COMPLETED

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.

Details

Lead sponsor	Cancer Research UK
Phase	Phase 1
Status	COMPLETED
Enrolment	45
Start date	2010-07
Completion	2015-02

Conditions

• Brain and Central Nervous System Tumors

Interventions

• glioblastoma multiforme multipeptide vaccine IMA950
• sargramostim
• temozolomide
• laboratory biomarker analysis
• pharmacological study
• adjuvant therapy
• radiation therapy

Primary outcomes

• 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

Countries

United Kingdom