Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer
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|ClinicalTrials.gov Identifier: NCT02865135|
Recruitment Status : Recruiting
First Posted : August 12, 2016
Last Update Posted : May 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Head and Neck Cancer of Cervix Cancer of Anus||Drug: DPX-E7 vaccine Drug: Cyclophosphamide||Phase 1 Phase 2|
This is a phase Ib/II clinical trial. DPX-E7 is a therapeutic vaccine, intended to treat HPV-related head and neck, cervical or anal cancer. DPX-E7 is an investigational vaccine and the FDA (the U.S. Food and Drug Administration) has not approved DPX-E7 vaccine as a treatment for any disease.
DPX-E7 is being tested in humans for the first time. DPX-E7 is a kind of immunotherapy that will make the immune system to elicit an anti-tumor response by generating CD8+ T-cells. CD8+ T-cells play a very important role in fighting against viral infections
Cyclophosphamide is used to treat various types of cancer. It is a biological modifier drug that works by slowing or stopping cell growth.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib/II Trial To Test The Safety And Efficacy Of Vaccination With HPV16-E711-19 Nanomer For The Treatment Of Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer In HLA-A*02 Positive Patients|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2023|
Experimental: DPX-E7 Vaccine With Cyclophosphamide
Subjects will 2 priming doses of DPX-E7 at a pre-determine dosage 3 weeks apart followed by a predetermine booster dose every 8 weeks until clinical progression.
Low dose metronomic oral Cyclophosphamide will start 7 days before vaccination, continue for 7 days on and then 7 days off, throughout the treatment period, until progression.
Drug: DPX-E7 vaccine
Therapeutic vaccine for the treatment of incurable HPV16-related oropharyngeal, cervical and anal cancer in HLA-A*02 positive patients.
Other Name: HPV vaccine
Cyclophosphamide is an alkylating drug indicated for treatment of multiple malignant diseases. In this study a low dose is being given in combination with the DPX-E7 vaccine.
- Number of Participants Experiencing Adverse Events Related to Treatment [ Time Frame: 2 years ]
- Overall Response Rate [ Time Frame: 2 years ]
- Overall Survival Rate [ Time Frame: 2 years ]
- Progression Free Survival Rate [ Time Frame: 2 years ]
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): NCT02865135
|Contact: Michelle Flynn, RN||617.582.9490||MFLYNN13@PARTNERS.ORG|
|Contact: Patricia McHugh, RN||617.632.6817||PMCHUGH@PARTNERS.ORG|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Michelle Flynn, RN 617-582-9490 MFLYNN13@PARTNERS.ORG|
|Contact: Patricia McHugh, RN 617.632.6817 PMCHUGH@PARTNERS.ORG|
|Principal Investigator: Jochen Lorch, MD|
|Principal Investigator:||Jochen Lorch, MD||Dana-Farber Cancer Institute, Boston, MA02215|