Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study (CAN-003X)
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| ClinicalTrials.gov Identifier: NCT01617629 |
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Recruitment Status :
Completed
First Posted : June 12, 2012
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
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Sponsor:
Prima BioMed Ltd
Information provided by (Responsible Party):
Prima BioMed Ltd
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epithelial Ovarian Cancer | Biological: MUC1 Dendritic Cell Vaccine (Cvac) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 9 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label Safety Trial of Cvac (Autologous Dendritic Cells Pulsed With Recombinant Human Fusion Protein Coupled to Oxidized Polymannose) for Epithelial Ovarian Cancer Patients Who Have Progressed During the CAN-003 Study |
| Study Start Date : | December 2011 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | April 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cvac Treatment Group
Participants received Epithelial Mucin Surface Antigen 1 (MUC1) Dendritic Cell Vaccine (Cvac) treatment.
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Biological: 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). |
Primary Outcome Measures :
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: First dose of study vaccine to 30 days past last dose (Approximately 1 Year) ]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.
Other Outcome Measures:
- Overall Survival [ Time Frame: 2 years ]Overall survival was defined as the time from randomization until death from any cause.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female patients ≥ 18 years old with histologically confirmed Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in CAN-003
- Able and willing to undergo mononuclear cell (MNC) collection (if required for patients who do not have available Cvac doses)
- Were enrolled in CAN-003 and met protocol criteria for progressive disease
- Wish to remain in the study and, in the investigator's judgment, the potential benefit of Cvac treatment outweighs the risk
- Must be non-pregnant and, if of childbearing potential, must use adequate birth control (hormonal or barrier method of birth control or abstinence) for the duration of the study and for 3 months after study completion
- Able to provide written informed consent
- White blood cell count (WBC) ≥ 3.0 K/μL, absolute neutrophil count ≥ 1.5 K/μL, hemoglobin ≥ 9.0 g/dL, and platelets ≥100,000/mm^3
Exclusion Criteria:
- Pregnant or breastfeeding
- Other medical conditions which preclude study participation, in the opinion of the investigator
- Receiving treatment with any other investigational product
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617629
Locations
| United States, California | |
| Marin Cancer Care, Inc. | |
| Greenbrae, California, United States, 94904 | |
| Scripps Cancer Center | |
| La Jolla, California, United States, 92037 | |
| United States, Florida | |
| Collaborative Research Group | |
| Boca Raton, Florida, United States, 33487 | |
| United States, Indiana | |
| Indiana University Simon Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98109 | |
| Australia, Queensland | |
| Greenslopes Private Hospital | |
| Greenslopes, Queensland, Australia, 4120 | |
Sponsors and Collaborators
Prima BioMed Ltd
Investigators
| Principal Investigator: | 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 School of Medicine | |
| Principal Investigator: | Fernando Recio, MD | Collaborative Research Group | |
| Principal Investigator: | Jeffery Goh, MBBS, FRACP | Greenslopes Private Hospital |
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.
| Responsible Party: | Prima BioMed Ltd |
| ClinicalTrials.gov Identifier: | NCT01617629 |
| Other Study ID Numbers: |
CAN-003X |
| First Posted: | June 12, 2012 Key Record Dates |
| Results First Posted: | December 8, 2017 |
| Last Update Posted: | December 8, 2017 |
| Last Verified: | November 2017 |
Keywords provided by Prima BioMed Ltd:
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Cvac |
Additional relevant MeSH terms:
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |