Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papillomavirus-Related Cancer in Adult Women After Kidney Transplant
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 16-002571
NCT ID: NCT03036930
Sponsor Protocol Number: NCI 2015-06-02
About this study
This phase II trial studies how well recombinant human papillomavirus nonavalent vaccine works in preventing human papillomavirus-related cancer in adult women after kidney transplant. Vaccines made from peptides of human papillomavirus may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- Female candidate for living donor renal transplant within 24 months of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
- Leukocytes >= 3,000/microliter
- Absolute neutrophil count >= 1,500/microliter
- Platelets >= 75,000/microliter
- Total bilirubin =< 2 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN
- ABO compatible with donor
- Panel reactive antibody (PRA) < 80%
- Women who are able to become pregnant must have a confirmed negative pregnancy test result prior to enrollment and must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- Ability to understand and the willingness to sign a written informed consent document and medical release form
- Willing and able to comply with trial protocol and follow-up
- Previous prophylactic HPV vaccination
- Prior organ transplant
- Anticipated desensitization treatment
- Current use of any other investigational agents
- History of allergic reactions to yeast or attributed to compounds of similar chemical or biologic composition to Gardasil 9 HPV vaccine
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or intention to get pregnant; pregnant women are excluded from this study
- Carcinoma in situ (CIS) of the cervix or history of cervical cancer
- History of active malignancy, including basal/squamous cell skin cancer
- Prior hysterectomy
- Concurrent illness, such as known psychiatric disorders or substance abuse (i.e., average alcohol consumption of more than 3 drinks per day), which in the opinion of the investigators would compromise either the patient or the integrity of the data
- Patients on anticoagulation or with bleeding disorders should be evaluated by a physician for risk/benefit of bleeding disorders with intramuscular injections prior to study enrollment; patients determined to be at high risk for bleeding with intramuscular injections will be excluded
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.