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Cancer Vaccine
HPV 16-Related Cancer Vaccine for Head and Neck, Anal, and Cervical Cancer
Phase 1 & 2
Waitlist Available
Led By Jochen Lorch, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the median follow up was 4.8 months (range 1.6 - 14.9 months).
Awards & highlights
Study Summary
This trial is testing a therapeutic vaccine, called DPX-E7, as a possible treatment for HPV-related head and neck, cervical, or anal cancer.
Eligible Conditions
- Head and Neck Cancers
- Cervical Cancer
- Anal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the median follow up was 4.8 months (range 1.6 - 14.9 months).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the median follow up was 4.8 months (range 1.6 - 14.9 months).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in CD8+ T Cells in Peripheral Blood and Tumor Tissue
Grade 1-2 Treatment-Related AE Rate
Number of Participants With Dose Limiting Toxicity (DLT) [Phase 1b]
Secondary outcome measures
Best Overall Response
Median Overall Survival
Median Progression-Free Survival
+1 moreSide effects data
From 2023 Phase 1 & 2 trial • 11 Patients • NCT02865135100%
Vomiting
67%
Depression
67%
Nausea
67%
Fatigue
33%
Aspartate aminotransferase increased
33%
Generalized muscle weakness
33%
Cholesterol high
33%
Stomach pain
33%
Gait disturbance
33%
Trismus
33%
Diarrhea
33%
Anemia
33%
Ear pain
33%
Constipation
33%
Hypoalbuminemia
33%
Dysphagia
33%
Peripheral motor neuropathy
33%
Hot flashes
33%
Genital edema
33%
Cough
33%
Dyspnea
33%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
DPX-E7 + Cyclophosphamide [Phase II Cohort 1]
DPX-E7 + Cyclophosphamide [Phase Ib Cohort]
DPX-E7 [Phase II Cohort 2]
Trial Design
3Treatment groups
Experimental Treatment
Group I: DPX-E7 [Phase II Cohort 2]Experimental Treatment1 Intervention
Participants were enrolled after amendment 10. Participants received two 0.50 mL priming doses of DPX-E7 3 weeks apart, followed by 0.2 mL booster dose every 8 weeks until clinical progression.
Group II: DPX-E7 + Cyclophosphamide [Phase Ib Cohort]Experimental Treatment2 Interventions
Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.
Group III: DPX-E7 + Cyclophosphamide [Phase II Cohort 1]Experimental Treatment2 Interventions
Participants were enrolled before amendment 10. Participants received: 1) 50 mg twice per day of cyclophosphamide orally 7 days before the vaccination, continuing for 7 days on and then 7 days off, throughout the treatment period; 2) two 0.25 mL priming doses of DPX-E7 3 weeks apart, followed by 0.1 mL booster dose every 8 weeks until clinical progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
DPX-E7 vaccine
2017
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,283 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,937 Total Patients Enrolled
Jochen Lorch, MDPrincipal InvestigatorDana-Farber Cancer Institute, Boston, MA02215
7 Previous Clinical Trials
196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have brain tumors that are growing, causing symptoms, or needing higher doses of medication to control.You cannot have received chemotherapy within the three weeks leading up to the start of the trial treatment.You have active hepatitis, HIV, or any other condition that requires medication to weaken your immune system. This includes taking high doses of corticosteroids.You have an autoimmune disease like lupus or arthritis that is active and requires ongoing treatment to suppress your immune system.You have a serious infection that is not under control.You have advanced stage HPV-related cancer that has spread to other parts of the body and cannot be cured with surgery or radiation.You have advanced cervical or anal cancer that has come back or spread, and there are no more treatment options available to cure it.
Research Study Groups:
This trial has the following groups:- Group 1: DPX-E7 + Cyclophosphamide [Phase Ib Cohort]
- Group 2: DPX-E7 + Cyclophosphamide [Phase II Cohort 1]
- Group 3: DPX-E7 [Phase II Cohort 2]
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this trial for new patients seeking help?
"This study, which can be found on clinicaltrials.gov, is not currently looking for new patients to test the medication. The trial was posted on December 1st 2016 and was last edited February 18th 2022. Although this particular trial isn't recruiting, there are 785 other trials that are actively searching for patients right now."
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