Renal Cell Carcinoma
Conditions
Keywords
Kidney cancer, Renal cancer
Brief summary
The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cell carcinoma.
Interventions
BIOLOGICALMB-002
Dendritic Cell Immunotherapy
Sponsors
Argos Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a new diagnosis of metastatic renal cell carcinoma; * Must be at least 18 years or older; * Have a scheduled unilateral nephrectomy; * ECOG of 0 or 1; * Free of brain metastases by CT or MRI; * Normal renal function in contralateral kidney; * Male or non-pregnant/non-lactating female on appropriate birth control methods while on study; * Clinically acceptable screening results. * No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry; * No active autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine the safety of multiple administrations of MB-002 in patients with newly diagnosed, metastatic renal cell carcinoma. | From registration until disease progression or withdrawal from study |
| To measure clinical antitumor activity including objective tumor response and an estimate of time to tumor progression (or progression-free interval). | From registration until disease progression or withdrawal from study |
Countries
Canada, United States
Outcome results
None listed