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Trial record 25 of 39 for:    Von Hippel-Lindau Disease (VHL)

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Group A-VHL Peptide and ISA-51 Adjuvant
STARTED   6 
Peptide Stock Completed   3 [1] 
COMPLETED   1 
NOT COMPLETED   5 
progressed disease                2 
No evidence of disease                1 
recurrent disease                2 
[1] off therapy reason for 3 patients



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
   Group A-VHL Peptide and ISA-51 Adjuvant 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   6 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (11.31) 
Gender 
[Units: Participants]
 
Female   1 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   6 


  Outcome Measures

1.  Primary:   Percentage of Participants Who Generated an Immune Response   [ Time Frame: 30 months ]

2.  Secondary:   The Number of Participants With Adverse Events.   [ Time Frame: 88 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Patients were enrolled to Arm A only due to poor accrual and the lack of peptide vaccine.


  More Information

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
e-mail: khleifs@mail.nih.gov


Publications:

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