NCT01171469

Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Progressive Malignant Brain Tumor

Phase I Study of Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Recurrent or Progressive Malignant Gliomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a single center Phase I study to determine the safety and maximum tolerated dose (MTD) of autologous dendritic cells (DCs) loaded with allogeneic brain tumor stem cells administered as a vaccination in children and adults with recurrent brain tumors. Once the MTD has been determined, we will conduct a phase II study to determine efficacy. Clinical trials that utilize DCs for immunotherapy have demonstrated significant survival benefit for patients who exhibit robust immune responses against tumor cells. Unfortunately, at the present time the majority of tumor patients are unable to mount an adequate immune response and thus succumb to their tumors. We postulate that the inability to generate an appropriate immune response in these patients is due to a lack of sufficient numbers of appropriate T cells due to an inadequate source of tumor antigens.

Detailed description

Autologous DCs will be obtained from peripheral blood mononuclear cells (PBMCs) from each patient by leukapheresis. An established BTSC line will be used as an allogeneic source of tumor antigen. Approximately 4 weeks will be required after the leukapheresis for vaccine production and the first vaccine administration. Each patient will receive an injection of DCs at his/her assigned dose once every 2 weeks during the first 8 weeks, followed by injections every 4 weeks for an additional 10 vaccinations. Imiquimod will be applied to the vaccination site just prior to and 24 hours after each vaccine administration. This study will use an accelerated dose escalation design (1 subject per level) until dose limiting toxicity (DLT) is encountered, after which a traditional phase I design (3 subjects per level) will be implemented. DLT is defined as grade 3 or greater treatment related toxicity. A total of 6 patients will be treated at the maximum tolerated dose (MTD) or, in the absence of DLT, at dose level 3.

Conditions

• Brain Tumor
• Glioblastoma
• Medulloblastoma
• Ependymoma
• Anaplastic Astrocytoma

Interventions

Type	Name	Description
BIOLOGICAL	Dendritic Cells	5, 10 or 15 Million dendritic cells (DCs) - administered via intradermal injections in 0.5 ml Phosphate Buffered Saline (PBS) in the shoulders near the back of the neck to facilitate trafficking of the DCs to the cervical lymph nodes.
DRUG	Imiquimod	Imiquimod (INN) is a prescription medication that acts as an immune response modifier. Imiquimod is marketed as 5% Aldara cream in 250 mg packets, providing a total dose of 12.5 mg per packet and sufficient to cover 20 square centimeters. The contents of ½ of a packet will be applied as a thin film to cover approximately 10 square centimeters of skin in the area of the planned vaccination.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2010-07-28
• Last updated: 2017-12-02

Locations

1 site across 1 country: United States