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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
Sponsor:
Collaborator:
Stand Up To Cancer
Information provided by (Responsible Party):
Jochen Lorch, MD, Dana-Farber Cancer Institute

Brief Summary:
This research study is studying a therapeutic vaccine, named DPX-E7, as a possible treatment for Human Papilloma Virus or HPV related head and neck, cervical or anal cancer (positive for HLA-A*02).

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

Detailed Description:

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer
U.S. FDA Resources

Arm Intervention/treatment
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
Drug: Cyclophosphamide
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.
Other Names:
  • Cytoxan
  • Neosar



Primary Outcome Measures :
  1. Number of Participants Experiencing Adverse Events Related to Treatment [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 2 years ]
  2. Overall Survival Rate [ Time Frame: 2 years ]
  3. Progression Free Survival Rate [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Each patient must be positive for HLA-A*02 and meet all of the following inclusion criteria to be enrolled in the study:
  • Histologically or cytologically proven HPVOC or cervical cancer or anal cancer, based on expression of HPV type16 in immunohistochemistry and/or HPV 16 DNA analysis by ISH of tumor tissue from the primary or metastatic lesions.
  • Incurable HPVOC, as defined by:

    • Relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. Surgery, radiotherapy or chemoradiotherapy) with no potentially curative option (i.e. surgery or radiation); OR
    • Distant metastasis
  • Incurable cervical or anal cancer, as defined by:

    • Relapsed or progressive disease at the primary site and/or regional lymph nodes after initial treatment (e.g. systemic chemotherapy) with no potentially curative option (i.e. surgery or chemoradiotherapy). Chemotherapy administered in conjunction with primary radiation as a radiosensitizer will not be counted as a systemic chemotherapy regimen; OR
    • Distant metastasis refractory to initial treatment (at least one prior chemotherapeutic regimen which can include a single chemotherapeutic, a combination of chemotherapeutics, or biologic drugs such as bevacizumab).
  • Accessible tumors for sequential biopsies Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.03) to grade 1 or better (except for < grade 2 neuropathy, alopecia, xerostomia, dysphagia, or mucositis);
  • Age ≥ 18 years;
  • Measurable disease, according to modified RECIST 1.1 and irRECIST (Appendix B & C);
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2 (Appendix A)
  • Adequate bone marrow, liver and renal function, defined by:

    • Hemoglobin ≥ 10 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1000/μL;
    • Absolute lymphocyte count ≥ 400/μL;
    • Platelet count ≥ 100,000/μL;
    • ALT and AST ≤ 2.5 X upper limit of normal (ULN);
    • Total bilirubin ≤ 1.5 X ULN; and
    • Serum creatinine ≤ 1.5 X ULN;
  • Women of child-bearing potential (WOCBP) must be willing to use acceptable means of birth control;
  • Men who could potentially father a child must also use birth control
  • Signed informed consent

Exclusion Criteria:

  • Radiotherapy for primary HPVOC within 8 weeks, or radiotherapy for any other reason within 3 weeks prior to the first dose of trial treatment;
  • Chemotherapy within 3 weeks prior to the first dose of trial treatment;Other cancer in the past 5 years, except for carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer;
  • Inaccessible tumor or lack of consent for sequential biopsies
  • Uncontrolled central nervous system (CNS) metastases (i.e. known CNS lesions that are radiographically unstable, symptomatic and/or requiring escalating doses of corticosteroids);
  • Active hepatitis, known HIV, or other condition that requires immunosuppressive therapy, including current use of high dose systemic corticosteroids;
  • Autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that is active and requires current immunosuppressive therapy;
  • Active uncontrolled serious infection;
  • WOCBP who have a positive β-hCG test or are breastfeeding.
  • Acute or chronic skin disorders that would interfere with subcutaneous injection of the vaccine or subsequent assessment of potential skin reactions;
  • Allergies to any vaccine, that after discussion with Immunovaccine, are serious enough to warrant exclusion from this study

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): NCT02865135


Contacts
Contact: Michelle Flynn, RN 617.582.9490 MFLYNN13@PARTNERS.ORG
Contact: Patricia McHugh, RN 617.632.6817 PMCHUGH@PARTNERS.ORG

Locations
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         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Stand Up To Cancer
Investigators
Principal Investigator: Jochen Lorch, MD Dana-Farber Cancer Institute, Boston, MA02215

Responsible Party: Jochen Lorch, MD, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02865135     History of Changes
Other Study ID Numbers: 15-578
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jochen Lorch, MD, Dana-Farber Cancer Institute:
HPV Related Head and Neck
Cervical
Anal Cancer

Additional relevant MeSH terms:
Anus Neoplasms
Head and Neck Neoplasms
Uterine Cervical Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vaccines
Cyclophosphamide
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action