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The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer eligible for study participation due to disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cvac Treatment Group | Experimental | Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MUC1 Dendritic Cell Vaccine (Cvac) | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | 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. | First dose of study vaccine to 30 days past last dose (Approximately 1 Year) |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the time from randomization until death from any cause. | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidy Gray, MD | University of Washington | Principal Investigator |
| James Mason, MD | Scripps Cancer Center | Principal Investigator |
| Peter Eisenberg, MD | Marin Cancer Care | Principal Investigator |
| Giuseppe Del Priore, MD | Indiana University | Principal Investigator |
| Fernando Recio, MD | Collaborative Research Group | Principal Investigator |
| Jeffery Goh, MBBS, FRACP | Greenslopes Private Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marin Cancer Care, Inc. | Greenbrae | California | 94904 | United States | ||
| Scripps Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7538768 | Background | Apostolopoulos V, McKenzie IF. Cellular mucins: targets for immunotherapy. Crit Rev Immunol. 1994;14(3-4):293-309. doi: 10.1615/critrevimmunol.v14.i3-4.40. | |
| 8912009 | Background | Apostolopoulos V, McKenzie IF, Pietersz GA. Breast cancer immunotherapy: current status and future prospects. Immunol Cell Biol. 1996 Oct;74(5):457-64. doi: 10.1038/icb.1996.76. |
| Label | URL |
|---|---|
| Related Info from Sponsor's Web Site | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cvac Treatment Group | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cvac Treatment Group | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | 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. | Safety Population included all participants who enrolled in the study. | Posted | Number | participants | First dose of study vaccine to 30 days past last dose (Approximately 1 Year) |
|
First dose of study vaccination to 30 days past last dose (Approximately 1 Year)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cvac Treatment Group | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incarcerated hernia | General disorders | MedDRA (13.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Voigt | PrimaBioMed, Ltd. | 49 173 6771602 | marc.voigt@primabiomed.com.au |
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C045771 | CCV-AV protocol |
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|
| La Jolla |
| California |
| 92037 |
| United States |
| Collaborative Research Group | Boca Raton | Florida | 33487 | United States |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| University of Washington Medical Center | Seattle | Washington | 98109 | United States |
| Greenslopes Private Hospital | Greenslopes | Queensland | 4120 | Australia |
| Background | 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). |
| 9548459 | Background | Apostolopoulos V, Karanikas V, Haurum JS, McKenzie IF. Induction of HLA-A2-restricted CTLs to the mucin 1 human breast cancer antigen. J Immunol. 1997 Dec 1;159(11):5211-8. |
| 12088472 | Background | Grossi M, Quinn MA, Thursfield VJ, Francis PA, Rome RM, Planner RS, Giles GG. Ovarian cancer: patterns of care in Victoria during 1993-1995. Med J Aust. 2002 Jul 1;177(1):11-6. doi: 10.5694/j.1326-5377.2002.tb04616.x. |
| 18287387 | Background | Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20. |
| 17704410 | Background | Liu PY, Alberts DS, Monk BJ, Brady M, Moon J, Markman M. An early signal of CA-125 progression for ovarian cancer patients receiving maintenance treatment after complete clinical response to primary therapy. J Clin Oncol. 2007 Aug 20;25(24):3615-20. doi: 10.1200/JCO.2006.09.4540. |
| 10789720 | Background | Meyer T, Rustin GJ. Role of tumour markers in monitoring epithelial ovarian cancer. Br J Cancer. 2000 May;82(9):1535-8. doi: 10.1054/bjoc.2000.1174. |
| Background | 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. |
| 10764434 | Background | Rustin GJ, Nelstrop AE, Bentzen SM, Bond SJ, McClean P. Selection of active drugs for ovarian cancer based on CA-125 and standard response rates in phase II trials. J Clin Oncol. 2000 Apr;18(8):1733-9. doi: 10.1200/JCO.2000.18.8.1733. |
| Participant Withdrew Consent |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Cvac Treatment Group |
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). |
|
|
| Other Pre-specified | Overall Survival | Overall survival was defined as the time from randomization until death from any cause. | Due to the few patients, Overall Survival could not be calculated. | Posted | 2 years |
|
|
| 2 |
| 9 |
| 2 |
| 9 |
| 7 |
| 9 |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Disease progression | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA (13.0) | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Gastric infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
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.
| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |