Trial Outcomes & Findings for Vaccine Therapy With Tumor Specific Mutated VHL Peptides in Adult Cancer Patients With Renal Cell Carcinoma (NCT NCT00001703)

Last Updated: 2014-07-25

Results Overview

The immunological response was assessed by in-vitro T cell cytokine production enzyme-linked immunosorbent spot (ELISPOT). From each patients, post-vaccination peripheral blood mononuclear cells (PBMC) were compared to pre-vaccination as a baseline. A positive ELISPOT result for the patients was defined as a total number of experimental spots in the post-vaccination sample of more than twofold above the total spots in the pre-vaccination sample.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

30 months

Results posted on

2014-07-25

Participant Flow

Between 40-60 total patients may be required for this protocol. Between 2-3 years would be required to enter all necessary patients.

Participant milestones

Participant milestones
Measure	Group A-VHL Peptide and ISA-51 Adjuvant Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
Overall Study STARTED	6
Overall Study Peptide Stock Completed	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A-VHL Peptide and ISA-51 Adjuvant Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
Overall Study progressed disease	2
Overall Study No evidence of disease	1
Overall Study recurrent disease	2

Baseline Characteristics

Vaccine Therapy With Tumor Specific Mutated VHL Peptides in Adult Cancer Patients With Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A-VHL Peptide and ISA-51 Adjuvant n=6 Participants Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 11.31 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 months

Outcome measures

Outcome measures
Measure	Group A-VHL Peptide and ISA-51 Adjuvant n=5 Participants Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
Percentage of Participants Who Generated an Immune Response	80 percentage of participants

SECONDARY outcome

Timeframe: 88 months

Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Outcome measures

Outcome measures
Measure	Group A-VHL Peptide and ISA-51 Adjuvant n=5 Participants Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
The Number of Participants With Adverse Events.	5 participants

Adverse Events

Group A-VHL Peptide and ISA-51 Adjuvant

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group A-VHL Peptide and ISA-51 Adjuvant n=6 participants at risk Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
General disorders Fatigue	83.3% 5/6 • Number of events 5 • 6 1/2 years
Skin and subcutaneous tissue disorders Injection site reaction	83.3% 5/6 • Number of events 5 • 6 1/2 years
Nervous system disorders Headaches	66.7% 4/6 • Number of events 4 • 6 1/2 years
Musculoskeletal and connective tissue disorders myalgia/arthralgia	33.3% 2/6 • Number of events 2 • 6 1/2 years
General disorders Fever	16.7% 1/6 • Number of events 1 • 6 1/2 years
Respiratory, thoracic and mediastinal disorders Nasal congestion	16.7% 1/6 • Number of events 1 • 6 1/2 years
Metabolism and nutrition disorders hyperglycemia	16.7% 1/6 • Number of events 1 • 6 1/2 years
Metabolism and nutrition disorders Hypernatremia	16.7% 1/6 • Number of events 1 • 6 1/2 years
Metabolism and nutrition disorders Hypocalcemia	16.7% 1/6 • Number of events 1 • 6 1/2 years
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	16.7% 1/6 • Number of events 1 • 6 1/2 years

Other adverse events

Other adverse events
Measure	Group A-VHL Peptide and ISA-51 Adjuvant n=6 participants at risk Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
General disorders Fatigue	83.3% 5/6 • Number of events 5 • 6 1/2 years
Skin and subcutaneous tissue disorders Injection site reaction	83.3% 5/6 • Number of events 5 • 6 1/2 years

Additional Information

Samir N. Khleif, M.D.

National Cancer Institute, National Institutes of Health

Phone: 301-496-0901

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place