MedTrace Logo

Study of Cancer Peptides Vaccine Plus GM-CSF as Adjuvant Treatment for High Risk (TXN2-3M0) or Metastatic Breast Cancer With No Evidence of Disease

NCT00674791 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-06-19

No results posted yet for this study

Summary

This study will evaluate the safety and feasibility of administering a peptide vaccine consisting of twelve different tumor-rejection antigens to patients with high risk (TxN2-3M0) or metastatic breast cancer with no evidence of disease following their completion of systemic therapy. The vaccine is designed to elicit immune responses against twelve different pathways that are essential to tumor growth, survival and metastasis.

Conditions

Interventions

BIOLOGICAL

OCPM Immunotherapeutic Vaccine

Patients will receive 1 injection into each thigh at each of 6 visits: week 0, week 1, week 2, week 4, week 5, and week 6. The first 9 patients will receive a 100 microgram dose and the second 9 patients a 1 milligram dose of the peptide mixture.

Sponsors & Collaborators

Principal Investigators

  • Michael Morse, M.D. · Duke University Cancer Center

  • Kimberly Blackwell, M.D. · Duke University Cancer Center

  • Ramila Philip, Ph.D. · Immunotope

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-01-31
Completion
2010-01-31

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 NCT00674791 on ClinicalTrials.gov