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Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408590
First Posted: December 7, 2006
Last Update Posted: October 2, 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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
Results First Submitted: May 4, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Ovarian Cancer
Primary Peritoneal Cavity Cancer
Interventions: Biological: carcinoembryonic antigen-expressing measles virus
Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter
Genetic: reverse transcriptase-polymerase chain reaction
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
Cohort 1, Dose Level 1 Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 1, these patients received a 10^3 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
Cohort 1, Dose Level 2 Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 2, these patients received a 10^4 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
Cohort 1, Dose Level 3 Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 3, these patients received a 10^5 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
Cohort 1, Dose Level 4 Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 4, these patients received a 10^6 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
Cohort 1, Dose Level 5 Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 5, these patients received a 10^7 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
Cohort 1, Dose Level 6 Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 6, these patients received a 10^8 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
Cohort 1, Dose Level 7 Cohort 1 consists of the first 21 patients accrued to the study before addendum13. At dose level 7, these patients received a 10^9 TCID50dose of MV-CEA diluted in 500 ml of normal saline over 30 minutes. They receive treatment every 4 weeks for a total of 6 cycles.
Cohort 2, Dose Level 1 Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 1, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10^8 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.
Cohort 2, Dose Level 2 Cohort 2 consists of the last 16 patients accrued to the study after addendum13. At dose level 2, these patients received one 0.025mg tablet of Cytomel 3 times a day for the 7 days leading up to a 10^9 TCID50 treatment of MV-NIS(every 4 weeks for up to 6 cycles). After this main treatment, they also received 5 mCi of Iodine, orally on days 3 and 8.

Participant Flow:   Overall Study
    Cohort 1, Dose Level 1   Cohort 1, Dose Level 2   Cohort 1, Dose Level 3   Cohort 1, Dose Level 4   Cohort 1, Dose Level 5   Cohort 1, Dose Level 6   Cohort 1, Dose Level 7   Cohort 2, Dose Level 1   Cohort 2, Dose Level 2
STARTED   3   3   3   3   3   3   3   3   13 
COMPLETED   3   3   3   3   3   3   3   3   13 
NOT COMPLETED   0   0   0   0   0   0   0   0   0 



  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
Cohort 1 Includes all dose levels of Cohort 1
Cohort 2 Includes all dose levels of Cohort 2
Total Total of all reporting groups

Baseline Measures
   Cohort 1   Cohort 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   16   37 
Age 
[Units: Years]
Median (Full Range)
 57 
 (43 to 82) 
 57.5 
 (35 to 82) 
 57 
 (35 to 82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21 100.0%      16 100.0%      37 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   21   16   37 
Ascites Present 
[Units: Participants with ascites]
 7   13   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Dose Limiting Toxicity   [ Time Frame: up to 12 months after last treatment ]

2.  Secondary:   Number of Responses (Complete and Partial, Stable and Progressive Disease)   [ Time Frame: up to 12 months after last treatment ]

3.  Secondary:   Change in CA-125 Levels From Baseline to Last Recorded Value (up to 18 Months)   [ Time Frame: baseline and up to 18 months ]

4.  Secondary:   Time to Progression   [ Time Frame: up to 12 months after last treatment ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Evanthia Galanis, M.D.
Organization: Mayo Clinic
phone: (507) 284-2511
e-mail: galanis.evanthia@mayo.edu



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00408590     History of Changes
Other Study ID Numbers: CDR0000515008
P30CA015083 ( U.S. NIH Grant/Contract )
MC0117 ( Other Identifier: Mayo Clinic Cancer Center )
1260-03 ( Other Identifier: Mayo Clinic - IRB )
NCI-2009-01199 ( Registry Identifier: CTRP )
First Submitted: December 6, 2006
First Posted: December 7, 2006
Results First Submitted: May 4, 2016
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017