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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

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ClinicalTrials.gov Identifier: NCT00408590
Recruitment Status : Active, not recruiting
First Posted : December 7, 2006
Results First Posted : October 2, 2017
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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
Enrollment 37

Recruitment Details  
Pre-assignment Details  
Arm/Group Title 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
Hide Arm/Group Description 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 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 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 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 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 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 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 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 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.
Period Title: Overall Study
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
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description Includes all dose levels of Cohort 1 Includes all dose levels of Cohort 2 Total of all reporting groups
Overall Number of Baseline Participants 21 16 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 21 participants 16 participants 37 participants
57
(43 to 82)
57.5
(35 to 82)
57
(35 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 16 participants 37 participants
Female
21
 100.0%
16
 100.0%
37
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 16 participants 37 participants
21 16 37
Ascites Present  
Measure Type: Number
Unit of measure:  Participants with ascites
Number Analyzed 21 participants 16 participants 37 participants
7 13 20
1.Primary Outcome
Title Dose Limiting Toxicity
Hide Description If one patient experiences a Dose limiting Toxicity(DLT), up to three additional patients will be treated at the same dose level. If DLT is observed in only one of six patients treated at a given dose level, the next cohort of three patients will be treated at the next higher dose level. If two or more patients experience DLT at a particular dose level, then the dose escalation will cease and any subsequent patients will be treated at a lower dose level. Thus finding the Max tolerated dose
Time Frame up to 12 months after last treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients that received study drug for at least 4 weeks were evaluated for dose limiting toxicities.
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
Includes all dose levels of Cohort 1
Includes all dose levels of Cohort 2
Overall Number of Participants Analyzed 21 16
Measure Type: Number
Unit of Measure: participants with DLTs
0 0
2.Secondary Outcome
Title Number of Responses (Complete and Partial, Stable and Progressive Disease)
Hide Description Responses will be summarized separately for the MV-CEA virus and MV-NIS virus by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease. CA125 levels and time to progression will also be summarized descriptively. Modified Response Evaluation Criteria in Solid Tumors(RECIST v1.0) criteria will be used. For target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter(LD) of target lesions; Progression (PD): As least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD
Time Frame up to 12 months after last treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
Includes all dose levels of Cohort 1
Includes all dose levels of Cohort 2
Overall Number of Participants Analyzed 21 16
Measure Type: Number
Unit of Measure: participants
CR 0 0
PR 0 0
SD 14 13
PD 7 3
3.Secondary Outcome
Title Change in CA-125 Levels From Baseline to Last Recorded Value (up to 18 Months)
Hide Description CA-125 tests are measured in units per milliliter (U/mL) and taken every cycle (up to 6-28 day cycles) during treatment and every three months up to 12 months after treatment. The change in CA-125 is calculated as the baseline CA-125 value subtracted by the last recorded value of CA-125 (up to 18 months from baseline.
Time Frame baseline and up to 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:
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 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 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 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 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 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 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 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 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.
Overall Number of Participants Analyzed 3 1 3 2 3 3 3 3 13
Median (Full Range)
Unit of Measure: U/ml
-20.2
(-57 to 61)
97
(97 to 97)
52
(-26 to 4300)
42.5
(-140 to 225)
129
(4 to 216)
-112
(-261 to -5)
11
(-8 to 21)
1200
(6 to 2800)
18
(-447 to 3033)
4.Secondary Outcome
Title Time to Progression
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame up to 12 months after last treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
Includes all dose levels of Cohort 1
Includes all dose levels of Cohort 2
Overall Number of Participants Analyzed 21 16
Median (Full Range)
Unit of Measure: Days
55
(21 to 277)
64.5
(26 to 277)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description Includes all dose levels of Cohort 1 Includes all dose levels of Cohort 2
All-Cause Mortality
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/21 (14.29%)      2/16 (12.50%)    
Gastrointestinal disorders     
Abdominal distension  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Abdominal pain  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Ascites  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Colonic obstruction  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Nausea  1  2/21 (9.52%)  2 0/16 (0.00%)  0
Small intestinal obstruction  1  2/21 (9.52%)  2 1/16 (6.25%)  1
Vomiting  1  2/21 (9.52%)  2 0/16 (0.00%)  0
General disorders     
Edema limbs  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Fatigue  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Infections and infestations     
Peritoneal infection  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Skin infection  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Investigations     
Creatine phosphokinase increased  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Creatinine increased  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Dehydration  1  2/21 (9.52%)  3 0/16 (0.00%)  0
Vascular disorders     
Hypotension  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Thrombosis  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/21 (100.00%)      16/16 (100.00%)    
Blood and lymphatic system disorders     
Hemoglobin decreased  1  6/21 (28.57%)  8 6/16 (37.50%)  12
Hemolysis  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Cardiac disorders     
Arrhythmia  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Atrial tachycardia  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Cardiac disorder  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Palpitations  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Sinus bradycardia  1  1/21 (4.76%)  6 0/16 (0.00%)  0
Sinus tachycardia  1  2/21 (9.52%)  3 2/16 (12.50%)  3
Ear and labyrinth disorders     
Tinnitus  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Endocrine disorders     
Endocrine disorder  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Eye disorders     
Extraocular muscle paresis  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Eye disorder  1  1/21 (4.76%)  2 0/16 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  6/21 (28.57%)  9 7/16 (43.75%)  10
Abdominal pain  1  16/21 (76.19%)  36 16/16 (100.00%)  33
Ascites  1  1/21 (4.76%)  1 1/16 (6.25%)  1
Constipation  1  6/21 (28.57%)  9 6/16 (37.50%)  11
Diarrhea  1  11/21 (52.38%)  12 9/16 (56.25%)  15
Dyspepsia  1  0/21 (0.00%)  0 1/16 (6.25%)  2
Flatulence  1  8/21 (38.10%)  13 7/16 (43.75%)  14
Gastritis  1  2/21 (9.52%)  2 1/16 (6.25%)  1
Gastrointestinal disorder  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Lower gastrointestinal hemorrhage  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Mucositis oral  1  2/21 (9.52%)  3 1/16 (6.25%)  1
Nausea  1  9/21 (42.86%)  13 9/16 (56.25%)  13
Rectal hemorrhage  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Small intestinal obstruction  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Stomach pain  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Vomiting  1  5/21 (23.81%)  6 8/16 (50.00%)  11
General disorders     
Chest pain  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Chills  1  4/21 (19.05%)  9 9/16 (56.25%)  20
Edema limbs  1  5/21 (23.81%)  9 4/16 (25.00%)  4
Fatigue  1  13/21 (61.90%)  26 10/16 (62.50%)  24
Fever  1  10/21 (47.62%)  16 10/16 (62.50%)  22
General symptom  1  1/21 (4.76%)  1 2/16 (12.50%)  3
Injection site reaction  1  1/21 (4.76%)  2 0/16 (0.00%)  0
Pain  1  7/21 (33.33%)  17 4/16 (25.00%)  5
Infections and infestations     
Bladder infection  1  1/21 (4.76%)  1 1/16 (6.25%)  1
Bronchitis  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Catheter related infection  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Infection  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Skin infection  1  1/21 (4.76%)  2 0/16 (0.00%)  0
Soft tissue infection  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Wound infection  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Intestinal stoma site bleeding  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Investigations     
Alanine aminotransferase increased  1  1/21 (4.76%)  3 1/16 (6.25%)  4
Alkaline phosphatase increased  1  1/21 (4.76%)  1 3/16 (18.75%)  5
Aspartate aminotransferase increased  1  3/21 (14.29%)  4 2/16 (12.50%)  3
Blood bilirubin increased  1  0/21 (0.00%)  0 1/16 (6.25%)  2
Creatinine increased  1  1/21 (4.76%)  1 2/16 (12.50%)  5
Laboratory test abnormal  1  0/21 (0.00%)  0 1/16 (6.25%)  2
Leukocyte count decreased  1  1/21 (4.76%)  3 4/16 (25.00%)  9
Lymphocyte count decreased  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Neutrophil count decreased  1  1/21 (4.76%)  5 3/16 (18.75%)  6
Platelet count decreased  1  0/21 (0.00%)  0 3/16 (18.75%)  6
Serum cholesterol increased  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Weight gain  1  0/21 (0.00%)  0 1/16 (6.25%)  4
Weight loss  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  9/21 (42.86%)  14 3/16 (18.75%)  4
Blood glucose increased  1  3/21 (14.29%)  7 3/16 (18.75%)  3
Dehydration  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Serum albumin decreased  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Serum calcium decreased  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Serum calcium increased  1  0/21 (0.00%)  0 1/16 (6.25%)  2
Serum glucose decreased  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Serum phosphate decreased  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Serum potassium decreased  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Serum potassium increased  1  5/21 (23.81%)  5 0/16 (0.00%)  0
Serum sodium decreased  1  2/21 (9.52%)  2 3/16 (18.75%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/21 (9.52%)  11 1/16 (6.25%)  1
Back pain  1  5/21 (23.81%)  9 0/16 (0.00%)  0
Bone pain  1  2/21 (9.52%)  2 1/16 (6.25%)  1
Myalgia  1  4/21 (19.05%)  11 1/16 (6.25%)  2
Pain in extremity  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Nervous system disorders     
Dizziness  1  2/21 (9.52%)  2 0/16 (0.00%)  0
Headache  1  5/21 (23.81%)  5 3/16 (18.75%)  6
Neurological disorder NOS  1  2/21 (9.52%)  2 1/16 (6.25%)  1
Peripheral motor neuropathy  1  1/21 (4.76%)  2 1/16 (6.25%)  1
Peripheral sensory neuropathy  1  1/21 (4.76%)  1 3/16 (18.75%)  7
Speech disorder  1  1/21 (4.76%)  1 1/16 (6.25%)  1
Syncope vasovagal  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Psychiatric disorders     
Anxiety  1  1/21 (4.76%)  1 2/16 (12.50%)  3
Depression  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Insomnia  1  3/21 (14.29%)  3 1/16 (6.25%)  2
Renal and urinary disorders     
Renal failure  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Urogenital disorder  1  0/21 (0.00%)  0 1/16 (6.25%)  2
Reproductive system and breast disorders     
Pelvic pain  1  0/21 (0.00%)  0 1/16 (6.25%)  2
Vaginal discharge  1  0/21 (0.00%)  0 2/16 (12.50%)  3
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  1/21 (4.76%)  1 1/16 (6.25%)  2
Cough  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Dyspnea  1  4/21 (19.05%)  4 2/16 (12.50%)  2
Laryngeal pain  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Respiratory disorder  1  1/21 (4.76%)  1 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  3/21 (14.29%)  4 0/16 (0.00%)  0
Dry skin  1  1/21 (4.76%)  3 0/16 (0.00%)  0
Pain of skin  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Pruritus  1  2/21 (9.52%)  3 2/16 (12.50%)  2
Rash desquamating  1  3/21 (14.29%)  5 3/16 (18.75%)  8
Skin disorder  1  1/21 (4.76%)  2 2/16 (12.50%)  2
Skin ulceration  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Sweating  1  0/21 (0.00%)  0 1/16 (6.25%)  1
Vascular disorders     
Flushing  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Hemorrhage  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Hypertension  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Hypotension  1  2/21 (9.52%)  2 1/16 (6.25%)  1
Thrombosis  1  1/21 (4.76%)  1 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
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
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: March 7, 2018