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Trial record 25 of 41 for:    Von Hippel-Lindau Disease (VHL)

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

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ClinicalTrials.gov Identifier: NCT00001703
Recruitment Status : Terminated (Due to poor accrual and lack of peptide vaccine)
First Posted : November 4, 1999
Results First Posted : June 14, 2012
Last Update Posted : July 25, 2014
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Carcinoma
Interventions Biological: incomplete Freund's adjuvant
Biological: von Hippel-Lindau peptide vaccine
Enrollment 6

Recruitment Details

Between 40-60 total patients may be required for this protocol.

Between 2-3 years would be required to enter all necessary patients.

Pre-assignment Details  
Arm/Group Title Group A-VHL Peptide and ISA-51 Adjuvant
Hide Arm/Group Description Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
Period Title: Overall Study
Started 6
Peptide Stock Completed 3 [1]
Completed 1
Not Completed 5
Reason Not Completed
progressed disease             2
No evidence of disease             1
recurrent disease             2
[1]
off therapy reason for 3 patients
Arm/Group Title Group A-VHL Peptide and ISA-51 Adjuvant
Hide Arm/Group Description Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
62  (11.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
1
  16.7%
Male
5
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Percentage of Participants Who Generated an Immune Response
Hide Description 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.
Time Frame 30 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A-VHL Peptide and ISA-51 Adjuvant
Hide Arm/Group Description:
Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of participants
80
2.Secondary Outcome
Title The Number of Participants With Adverse Events.
Hide Description Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 88 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A-VHL Peptide and ISA-51 Adjuvant
Hide Arm/Group Description:
Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
5
Time Frame 6 1/2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A-VHL Peptide and ISA-51 Adjuvant
Hide Arm/Group Description Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
All-Cause Mortality
Group A-VHL Peptide and ISA-51 Adjuvant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group A-VHL Peptide and ISA-51 Adjuvant
Affected / at Risk (%) # Events
Total   5/6 (83.33%)    
General disorders   
Fatigue   5/6 (83.33%)  5
Fever   1/6 (16.67%)  1
Metabolism and nutrition disorders   
hyperglycemia   1/6 (16.67%)  1
Hypernatremia   1/6 (16.67%)  1
Hypocalcemia   1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders   
myalgia/arthralgia   2/6 (33.33%)  2
Nervous system disorders   
Headaches   4/6 (66.67%)  4
Respiratory, thoracic and mediastinal disorders   
Nasal congestion   1/6 (16.67%)  1
Allergic rhinitis   1/6 (16.67%)  1
Skin and subcutaneous tissue disorders   
Injection site reaction   5/6 (83.33%)  5
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A-VHL Peptide and ISA-51 Adjuvant
Affected / at Risk (%) # Events
Total   5/6 (83.33%)    
General disorders   
Fatigue   5/6 (83.33%)  5
Skin and subcutaneous tissue disorders   
Injection site reaction   5/6 (83.33%)  5
Indicates events were collected by systematic assessment
Patients were enrolled to Arm A only due to poor accrual and the lack of peptide vaccine.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Samir N. Khleif, M.D.
Organization: National Cancer Institute, National Institutes of Health
Phone: 301-496-0901
Responsible Party: Samir N. Khleif, M.D., National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00001703     History of Changes
Obsolete Identifiers: NCT00019526
Other Study ID Numbers: 980139
98-C-0139 ( Other Identifier: Clinical Center, NationaI Institutes of Health )
98-C-0139 ( Other Identifier: Clinical Center, National Institutes of Health )
First Submitted: November 3, 1999
First Posted: November 4, 1999
Results First Submitted: May 17, 2011
Results First Posted: June 14, 2012
Last Update Posted: July 25, 2014