HPV-16/18 E6/E7-Specific T Lymphocytes in Patients With Relapsed HPV-Associated Cancers


Condition: Human Papillomavirus-Related Carcinoma, Human Papillomavirus Positive Oropharyngeal Carcinoma, Human Papillomavirus Positive Cervical Carcinoma, Human Papillomavirus Positive Anal Carcinoma, Human Papillomavirus Positive Vulvar Carcinoma, Human Papillomavirus Positive Penile Carcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02379520

Sponsor: Baylor College of Medicine

Phase: Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • PROCUREMENT 1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample 2. Cancer is:
  • recurrent or persistent after standard therapy
  • OR patient is unable to receive standard therapy 3. Karnofsky score ≥ 50% 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent TREATMENT 1. Diagnosis of a cancer for which the presence of a high risk HPV type has been documented in a biopsy sample 2. Cancer is:
  • recurrent or persistent after standard therapy
  • OR patient is unable to receive standard therapy 3. Life expectancy ≥ 6 weeks. 4. Age ≥ 18 years. 5. Karnofsky score ≥ 50% 6. Bilirubin < 3 × upper limit of normal (ULN), AST < 5 × ULN, Hgb ≥ 7.0 g/dL 7. Pulse oximetry of > 90% on room air. 8. GFR > 30 mL/min calculated by the Cockcroft-Gault, MDRD study, or CKD-EPI creatinine equations, or equivalent 9. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent 10. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.

Exclusion Criteria:

  1. PROCUREMENT
  2. Known HIV positivity. TREATMENT
  3. Currently receiving any investigational agents or have received any tumor vaccines or T cell antibodies within previous 4 weeks.
  4. Severe intercurrent infection.
  5. Pregnancy or lactation.

View trial on ClinicalTrials.gov