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A Phase I Clinical Trial of Autologous Dendritic Cell Vaccine for Recurrent Ovarian or Primary Peritoneal Cancer

NCT00683241 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-02-26

No results posted yet for this study

Summary

This study is open to women with recurrent epithelial ovarian carcinoma or primary peritoneal cancer. Subjects will be asked to donate either a piece of their tumor or malignant effusion in order to make the first part of the vaccine or lysate. If enough of the lystate had been collected to make the first part of the vaccine, then subjects may enroll in the study as long as they meet the rest of the entry criteria.

After is determined that a subject is eligible to enroll into the study, you will have to donate some blood in order to make the second part of the vaccine. After this, the blood and vaccine are mixed together to make the vaccine called DCVax-L. You will be given two dose of a drug called Avastin every other week (Avastin will be given through your vein) and a oral chemotherapy called Cytoxan. One week after your last dose of oral Cytoxan, you will receive 3 vaccines given every other week for the next month. After the first two doses of vaccine, you will also receive more Avastin. During the study you will be seeing your study team to have physical exams, blood drawn in order to monitor your health and have blood drawn for research. The study team will contact you for the next 5 years in order to determine how you are doing.

Conditions

Interventions

BIOLOGICAL

DCVac-L

Subjects will receive three doses of intradermal vaccination with \~5-10 x 106 dendritic cells (DCVax-L) on days 0, 14 and 28

Sponsors & Collaborators

Principal Investigators

  • George Coukos, M.D., Ph.D. · University of Pennsylvania

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00683241 on ClinicalTrials.gov