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Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003895
First Posted: July 18, 2003
Last Update Posted: February 20, 2017
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: April 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Melanoma
Stage IA Melanoma
Stage IB Melanoma
Stage IIA Melanoma
Stage IIB Melanoma
Stage IIC Melanoma
Stage IIIA Melanoma
Stage IIIB Melanoma
Stage IIIC Melanoma
Interventions: Biological: HPV 16 E7:12-20
Biological: gp100:209-217(210M)
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
gp100:209-217(210M)and HPV 16 E7:12-20 (Every 2 Weeks)

Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.

HPV 16 E7:12-20 peptide vaccine: Given SC

gp100:209-217(210M) peptide vaccine: Given SC

laboratory biomarker analysis: Correlative studies

gp100:209-217(210M) and HPV 16 E7:12-20 (Every 3 Weeks)

Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.

HPV 16 E7:12-20 peptide vaccine: Given SC

gp100:209-217(210M) peptide vaccine: Given SC

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    gp100:209-217(210M)and HPV 16 E7:12-20 (Every 2 Weeks)   gp100:209-217(210M) and HPV 16 E7:12-20 (Every 3 Weeks)
STARTED   18   18 
COMPLETED   11   14 
NOT COMPLETED   7   4 
Adverse Event                4                0 
Lack of Efficacy                1                1 
Patient Vacation                2                0 
Withdrawal by Subject                0                3 



  Baseline Characteristics
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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
Arm A (Every 2 Weeks) No text entered.
Arm B (Every 3 Weeks) No text entered.
Total Total of all reporting groups

Baseline Measures
   Arm A (Every 2 Weeks)   Arm B (Every 3 Weeks)   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   36 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      14  77.8%      14  77.8%      28  77.8% 
>=65 years      4  22.2%      4  22.2%      8  22.2% 
Gender 
[Units: Participants]
Count of Participants
     
Female      7  38.9%      9  50.0%      16  44.4% 
Male      11  61.1%      9  50.0%      20  55.6% 


  Outcome Measures

1.  Primary:   T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide   [ Time Frame: Baseline to 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Walter J. Urba, MD, PhD; Physician Director of Research
Organization: Providence Cancer Center, Earle A. Chiles Research Institute, Robert W. Franz Cancer Center
phone: 503-215-5696
e-mail: Walter.Urba@providence.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003895     History of Changes
Obsolete Identifiers: NCT02009657
Other Study ID Numbers: NCI-2013-02096
NCI-2013-02096 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000067065
NCI-T98-0081
PPMC-IRB-99-9 ( Other Identifier: Providence Portland Medical Center )
99-9 ( Other Identifier: Providence Portland Medical Center )
T98-0081 ( Other Identifier: CTEP )
R21CA082614 ( U.S. NIH Grant/Contract )
First Submitted: November 1, 1999
First Posted: July 18, 2003
Results First Submitted: April 28, 2015
Results First Posted: February 20, 2017
Last Update Posted: February 20, 2017