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Survivin Vaccine : Multiple Myeloma Autologous Hematopoietic Cell Transplant (HCT)

NCT02851056 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-11-14

No results posted yet for this study

Summary

The purpose of this study is to test what effects (good and bad) a new cancer vaccine will have on participants and their cancer, when administered before and after their autologous hematopoietic cell transplant (HCT).

The name of the vaccine is called Dendritic Cell Survivin Vaccine (DC:AdmS). The vaccine is made using the participant's own blood cells. The vaccine will contain a virus called an adenovirus, similar the virus that causes the common cold. The virus has been changed so it cannot infect humans and cause infections. The vaccine will be prepared at Moffitt Cancer Center in the Cell Therapy Laboratory Facility.

Conditions

Interventions

BIOLOGICAL

Survivin Vaccine

Pre-transplant vaccination : The target dose of Survivin+ Dendritic cells (survivin+, CD11c+, Human Leukocyte Antigen - antigen D Related (HLA-DR)+ by flow-cytometry) is 15 x 10\^6 cells. A minimum of 1 x 10\^6 cells and a maximum of 20 x 10\^6 cells will be administered. Post-transplant vaccination: The target dose of Survivin+ Dendritic cells (survivin+, CD11c+, HLA-DR+ by flow-cytometry) is 15 x 10\^6 cells. A minimum of 1 x 10\^6 cells and a maximum of 20 x 10\^6 cells will be administered.

PROCEDURE

Autologous Hematopoietic Cell Transplantation

The participant's own cells are collected from their blood, frozen, and then given back to them after they receive chemotherapy.

BIOLOGICAL

Prevnar 13

13-Valent Pneumococcal Conjugate Vaccine (PCV13, Prevnar13). Co-Immunization: All participants will be co-immunized with Prevnar at each time they receive the survivin vaccine. This vaccine will be administered intramuscular (IM) 0.5cc.

DRUG

Granulocyte-colony Stimulating Factor

After the first survivin vaccination, participants will be mobilized with G-CSF.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Frederick Locke, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-27
Primary Completion
2018-07-16
Completion
2018-08-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02851056 on ClinicalTrials.gov