Trial Outcomes & Findings for Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF (NCT NCT00458536)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

38 participants

Primary outcome timeframe

6 months following last dose of treatment, up to 9 months

Results posted on

2026-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Treated With Vaccine Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
Overall Study STARTED	38
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Treated With Vaccine Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
Overall Study Disease progression prior to treatment	7
Overall Study Unable to make vaccine	3
Overall Study No measurable disease after surgery	2
Overall Study Did not have renal cell carcinoma	2
Overall Study Patient did not have surgery	1
Overall Study Ineligible due to toxicity	1
Overall Study Withdrawal by Subject	1
Overall Study Progressive disease during treatment	2

Baseline Characteristics

Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Treated With Vaccine n=19 Participants Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
Age, Customized	56 years n=30 Participants
Sex: Female, Male Female	6 Participants n=30 Participants
Sex: Female, Male Male	13 Participants n=30 Participants
Region of Enrollment United States	19 participants n=30 Participants

PRIMARY outcome

Timeframe: 6 months following last dose of treatment, up to 9 months

Population: Adverse events potentially related to vaccination were largely restricted to injection site reactions. 12 of the 19 patients experienced vaccine site reactions.

Outcome measures

Outcome measures
Measure	Patients Treated With Vaccine n=19 Participants Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
Number of Participants With Adverse Events Associated With Vaccination With Mature DC/Tumor Fusion and GM-CSF	12 participants

SECONDARY outcome

Timeframe: Pre-vaccine and 6 months post vaccine

Population: 11 patients had samples at both pre-vaccine and 6 months post vaccine and were able to be included in this analysis.

Interferon gamma levels were assessed to determine if cellular and humoral immunity is induced by serial vaccination with DC/tumor fusion cells and GM-CSF. This is a way to measure immunologic response following vaccination.

Outcome measures

Outcome measures
Measure	Patients Treated With Vaccine n=11 Participants Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
Number of Participants Who Demonstrated a Two-fold Increase in Interferon Gamma	5 Participants

Adverse Events

Patients Treated With Vaccine

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients Treated With Vaccine n=19 participants at risk Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
Investigations Injection Site Reaction	63.2% 12/19 • Number of events 25 • AEs were collected from the initiation of treatment through 6 months following the last vaccine, up to a total of 9 months for each participant.
Blood and lymphatic system disorders Bruising (at site of vaccine)	15.8% 3/19 • Number of events 7 • AEs were collected from the initiation of treatment through 6 months following the last vaccine, up to a total of 9 months for each participant.
Musculoskeletal and connective tissue disorders Arthralgias	5.3% 1/19 • Number of events 2 • AEs were collected from the initiation of treatment through 6 months following the last vaccine, up to a total of 9 months for each participant.
Investigations Urticaria	5.3% 1/19 • Number of events 1 • AEs were collected from the initiation of treatment through 6 months following the last vaccine, up to a total of 9 months for each participant.

Additional Information

David Avigan, MD

Beth Israel Deaconess Medical Center

Phone: 617-667-9920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place