Phase 2
Completed N=38
Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF
Source: ClinicalTrials.gov NCT00458536 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF — 12 participants
Summary
The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any side effects associated with this study vaccine. GM-CSF is similar to a substance in the body that stimulates the production of white blood cells. To create the study vaccine, cells will be removed from the participants tumor and fused with dendritic cells which are obtained from the participants blood. Dendritic cells are responsible for immune responses to "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF |
12 | — |
| SECONDARY Number of Participants Who Demonstrated a Two-fold Increase in Interferon Gamma |
5 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with stage IV renal cancer who have not received prior chemotherapy or biological therapy
- Patients who are to undergo debulking nephrectomy for independent clinical indications or patients with other sites of accessible disease
- Tumor tissue should be at least 2.0cm in longest dimension
- Patients should meet prognostic criteria for intermediate or favorable risk disease as defined by Motzer criteria
- Measurable metastatic disease as defined by a lesion of at least 1cm outside the lesion used for vaccine generation and exclusive of bony metastases
- ECOG Performance Status of 0-2 with greater than six week life expectancy
- 18 years of age or older
- Lab results within range outlined in protocol
Exclusion Criteria
- Patients who have received prior chemotherapy
- Clinical evidence of CNS disease. Patients with a history of treated brain metastasis must be stable with no evidence of disease for 3 months
- HIV positive
- Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure
- Pregnant of lactating women
- History of clinically significant venous thromboembolism
Data sourced from ClinicalTrials.gov (NCT00458536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.