HPV Vaccine Combination for Cancer
(J21112LINKED Trial)

Recruiting in Palo Alto (17 mi)

Dr. Tanguy Lim-Seiwert, MD - Baltimore ...

Overseen byTanguy Seiwert, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Trial Summary

What is the purpose of this trial?

This healthy related donor clinical trial is linked to a recipient clinical trial protocol for therapeutic purposes. In this healthy donor protocol, haploidentical relatives of a patient with recurrent or metastatic human papilloma virus (R/M HPV) 16-associated malignancy will be invited to be vaccinated with a therapeutic HPV vaccine series (PVX1) to generate HPV-specific white blood cells. In the linked recipient phase 1 clinical trial protocol, patient with incurable, locally recurrent or metastatic HPV 16-associated head and neck cancer will be randomized to one of two arms: Arm A: non-myeloablative (NMA) allogeneic bone marrow transplant (alloBMT) OR Arm B: CD8-depleted donor lymphocyte infusion (DLI) on Day 0 of a dose escalation scheme These two clinical trials are separated so that the healthy donor trial deals exclusively with issues of safety and immunological efficacy of the HPV vaccine series and this companion recipient trial examines the safety, feasibility and clinically efficacy of the allogeneic bone marrow graft and CD8-depleted DLI. The central hypothesis of the clinical trial is that patients with R/M HPV-associated malignancies can be safely and effectively treated by allogeneic bone marrow transplantation and/or CD8-depleted DLI from a healthy related donor that has been vaccinated against HPV16 E6 and E7 proteins.

Research Team

Tanguy Seiwert, M.D.

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria

This trial is for healthy relatives of patients with recurrent or metastatic HPV 16-related cancers. Participants must be haploidentical to the patient and willing to receive an HPV vaccine series to help generate specific white blood cells.

Inclusion Criteria

I am generally healthy with no significant medical issues.

Lymphocyte number ≥ 500

Absolute neutrophil count ≥ 1,000

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Exclusion Criteria

I have not had any cancer except for nonmelanoma skin cancer in the last 5 years.

History or presence of atopic dermatitis

I do not have an active or chronic HIV, HCV, or HBV infection.

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Treatment Details

Interventions

pNGVL4a-Sig/E7(Detox)/HSP70 (Cancer Vaccine)
TA-HPV (Virus Therapy)

Trial OverviewThe study tests a therapeutic HPV vaccine series on healthy donors, who are relatives of cancer patients, to see if it's safe and can stimulate an immune response. The linked recipient trial then uses these vaccinated donor cells in two different treatment approaches for the cancer patients.

Participant Groups

2Treatment groups

Active Control

Group I: Blood Donation Only for Recipient's CD-8 Depleted DLIActive Control1 Intervention

Donor patients receive the vaccination series followed by collection of peripheral blood. This blood will be used to create the CD8-depleted donor lymphocyte infusion (DLI) which will be given to the donor's related recipient patient on the J21112 study.

Group II: Blood and Bone Marrow Donation for Recipient Patient's alloBMTActive Control1 Intervention

Donor patients receive the vaccination series. This will be followed by a bone marrow harvest under anesthesia that will be given to the donor's related recipient patient on the J21112 study. Then, depending on recipient response to allogeneic BMT, donor may return for collection of peripheral blood used to create CD8-depleted donor lymphocyte infusion (DLI) which will be given to the donor's related recipient patient on D90.