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Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) and Imiquimod

NCT00799110 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-06-11

No results posted yet for this study

Summary

This research study is evaluating the effect (good and bad) of a dendritic cell/tumor fusion vaccine in combination with the laboratory made agents GM-CSF and imiquimod on the participants immune system. Another purpose of this study is to determine the type and severity of any side effects associated with this new study vaccine. We will also be evaluating what effect the vaccine has on the participants cancer. Dendritic cell vaccines have already been tested in clinical trials involving participants with many different types of cancer. Dendritic cells are powerful immune-stimulating cells that are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body.

Conditions

Interventions

DRUG

GM-CSF

Injections given subcutaneously at the sight of vaccination on the day of the vaccination and for three days afterwards

BIOLOGICAL

Dendritic Cell/Tumor Fusion Vaccine

Given subcutaneously once every three weeks for a total of three vaccines

DRUG

imiquimod

Cream applied to the skin at the injection sight 2 hours before injection and for 3 days following the injection

Sponsors & Collaborators

Principal Investigators

  • David Avigan, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00799110 on ClinicalTrials.gov