Clinical Trials /

Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer

NCT02865135

Description:

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).

Related Conditions:
  • Anal Carcinoma
  • Cervical Carcinoma
  • Oropharyngeal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Trial To Test Safety And Efficacy Of Vaccination For Incurable HPV 16-Related Oropharyngeal, Cervical And Anal Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 15-578
  • NCT ID: NCT02865135

Conditions

  • Cancer of Head and Neck
  • Cancer of Cervix
  • Cancer of Anus

Interventions

DrugSynonymsArms
DPX-E7 vaccineHPV vaccineDPX-E7 Vaccine With Cyclophosphamide
CyclophosphamideCytoxan, NeosarDPX-E7 Vaccine With Cyclophosphamide

Purpose

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).

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.

Trial Arms

NameTypeDescriptionInterventions
DPX-E7 Vaccine With CyclophosphamideExperimentalSubjects 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.
  • DPX-E7 vaccine
  • Cyclophosphamide

Eligibility 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

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants Experiencing Adverse Events Related to Treatment
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Response Rate
Time Frame:2 years
Safety Issue:
Description:
Measure:Overall Survival Rate
Time Frame:2 years
Safety Issue:
Description:
Measure:Progression Free Survival Rate
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Dana-Farber Cancer Institute

Trial Keywords

  • HPV Related Head and Neck
  • Cervical
  • Anal Cancer

Last Updated

December 13, 2016