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Trial record 14 of 204 for:    Ovarian Dysgenesis 1

Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study (CAN-003X)

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: NCT01617629
Recruitment Status : Completed
First Posted : June 12, 2012
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Prima BioMed Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epithelial Ovarian Cancer
Intervention Biological: MUC1 Dendritic Cell Vaccine (Cvac)
Enrollment 9
Recruitment Details Participants with ovarian cancer who participated in CAN-003 [NCT01068509] and had disease progression were enrolled in CAN-003x in Australia and the United States from December 2011 to April 2014.
Pre-assignment Details  
Arm/Group Title Cvac Treatment Group
Hide Arm/Group Description

Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.

MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).

Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).

Period Title: Overall Study
Started 9
Completed 3
Not Completed 6
Reason Not Completed
Death             2
Investigator's Clinical Judgement             1
Reason Not Specified             1
Participant Withdrew Consent             2
Arm/Group Title Cvac Treatment Group
Hide Arm/Group Description

Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.

MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).

Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
Safety population included all participants who enrolled in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
55.3  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
9
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 9 participants
9
 100.0%
1.Primary Outcome
Title Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Hide Description An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Time Frame First dose of study vaccine to 30 days past last dose (Approximately 1 Year)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population included all participants who enrolled in the study.
Arm/Group Title Cvac Treatment Group
Hide Arm/Group Description:

Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.

MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).

Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
Adverse Events 7
Serious Adverse Events 2
2.Other Pre-specified Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from randomization until death from any cause.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the few patients, Overall Survival could not be calculated.
Arm/Group Title Cvac Treatment Group
Hide Arm/Group Description:

Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.

MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).

Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cvac Treatment Group
Hide Arm/Group Description

Participants received MUC1 Dendritic Cell Vaccine (Cvac) treatment.

MUC1 Dendritic Cell Vaccine (Cvac): The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).

Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).

All-Cause Mortality
Cvac Treatment Group
Affected / at Risk (%)
Total   2/9 (22.22%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cvac Treatment Group
Affected / at Risk (%)
Total   2/9 (22.22%) 
General disorders   
Incarcerated hernia  1  1/9 (11.11%) 
Disease progression  1  1/9 (11.11%) 
Injury, poisoning and procedural complications   
Wound complication  1  1/9 (11.11%) 
1
Term from vocabulary, MedDRA (13.0)
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%
Cvac Treatment Group
Affected / at Risk (%)
Total   7/9 (77.78%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  2/9 (22.22%) 
Lymph node pain  1  1/9 (11.11%) 
Lymphadenopathy  1  1/9 (11.11%) 
Neutropenia  1  2/9 (22.22%) 
Thrombocytopenia  1  1/9 (11.11%) 
Eye disorders   
Blepharospasm  1  1/9 (11.11%) 
Gastrointestinal disorders   
Abdominal hernia  1  1/9 (11.11%) 
Constipation  1  1/9 (11.11%) 
Diarrhoea  1  2/9 (22.22%) 
Haemorrhoidal haemorrhage  1  1/9 (11.11%) 
Mouth ulceration  1  1/9 (11.11%) 
Nausea  1  1/9 (11.11%) 
Umbilical hernia  1  1/9 (11.11%) 
General disorders   
Chills  1  1/9 (11.11%) 
Fatigue  1  1/9 (11.11%) 
Influenza like illness  1  1/9 (11.11%) 
Injection site pruritus  1  1/9 (11.11%) 
Oedema peripheral  1  1/9 (11.11%) 
Infections and infestations   
Ear infection  1  1/9 (11.11%) 
Fungal infection  1  1/9 (11.11%) 
Gastric infection  1  1/9 (11.11%) 
Lower respiratory tract infection  1  1/9 (11.11%) 
Rash pustular  1  2/9 (22.22%) 
Sinusitis  1  1/9 (11.11%) 
Injury, poisoning and procedural complications   
Contusion  1  1/9 (11.11%) 
Ligament sprain  1  1/9 (11.11%) 
Metabolism and nutrition disorders   
Hypokalaemia  1  1/9 (11.11%) 
Hypomagnesaemia  1  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  1/9 (11.11%) 
Muscle twitching  1  1/9 (11.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Ovarian cancer  1  1/9 (11.11%) 
Nervous system disorders   
Dizziness  1  1/9 (11.11%) 
Headache  1  1/9 (11.11%) 
Hypoaesthesia  1  1/9 (11.11%) 
Lethargy  1  1/9 (11.11%) 
Peripheral sensory neuropathy  1  1/9 (11.11%) 
Restless legs syndrome  1  1/9 (11.11%) 
Sciatica  1  1/9 (11.11%) 
Psychiatric disorders   
Abnormal dreams  1  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/9 (11.11%) 
Dyspnoea  1  2/9 (22.22%) 
Sneezing  1  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Increased tendency to bruise  1  1/9 (11.11%) 
Rash  1  2/9 (22.22%) 
Rash macular  1  1/9 (11.11%) 
Rosacea  1  1/9 (11.11%) 
Vascular disorders   
Flushing  1  1/9 (11.11%) 
1
Term from vocabulary, MedDRA (13.0)
Indicates events were collected by systematic assessment
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.
For study centers in Australia, no publication of the study results may be made until publication of the results of the study from all centers or until 2 years after study completion, whichever is sooner. For study centers in the USA, no submission for publication or public disclosure of the results by will be made until the results from all centers have been received and analyzed by the sponsor, or the multi-center study has been terminated or abandoned at all centers.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marc Voigt
Organization: PrimaBioMed, Ltd.
Phone: 49 173 6771602
EMail: marc.voigt@primabiomed.com.au
Publications:
Desai J, Mitchell P, Loveland B, et al. A phase I trial of dendritic cells pulsed with MUC1 peptide in patients with solid tumours. Proc ASCO 2002; 21:15b (A1868).
Ozols RF, Rubin SC, Thomas G, et al. Epithelial ovarian cancer. In: Hoskins WJ, Perez CA, Young RC, eds. Principles and Practice of Gynecologic Oncology, 4th ed. Philadelphia: Lippincott Williams & Wilkins. 2005:919-922.
Layout table for additonal information
Responsible Party: Prima BioMed Ltd
ClinicalTrials.gov Identifier: NCT01617629     History of Changes
Other Study ID Numbers: CAN-003X
First Submitted: June 8, 2012
First Posted: June 12, 2012
Results First Submitted: November 10, 2017
Results First Posted: December 8, 2017
Last Update Posted: December 8, 2017