NCT01525017

A Clinical Study to Evaluate Safety and Immunologic Response of COMBIG-DC, in Patients With Metastatic Kidney Cancer

A Phase I Open-label Study to Evaluate Safety and Immunologic Response of COMBIG-DC Administered Intratumorally in Patients With Metastatic Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mendus · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to answer the question "Is it possible to inject the Combig-DC vaccine in a renal tumour without getting unacceptable side effects"? Patients newly diagnosed with metastatic renal cell carcinoma will get Combig-DC vaccinations at two occasions in a two weeks period (day 1 and day 14). After another two weeks the kidney will be eliminated. Adverse events will be registered, as well as changes in vital signs(heart rate, blood pressure and body temperature) and lab parameters. Immunologic response will be evaluated by measuring immunologic markers in blood and tumour tissue, and measuring the size of the metastases three months after nephrectomy.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Combig-DC (allogeneic dendritic cells) Cancer Vaccine	Cryopreserved dendritic cell suspension of 10 million cells per ml in heat-inactivated plasma, supplemented with 10% dimethyl sulfoxide (DMSO).

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-02-02
• Last updated: 2015-10-12

Locations

1 site across 1 country: Sweden