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A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant With Ovarian, Tubal or Peritoneal Cancer

NCT00437502 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-11-19

No results posted yet for this study

Summary

This study will evaluate the safety of administering a peptide vaccine consisting of twelve different tumor-rejection antigens known to be present on ovarian tumor cells. The vaccine is designed to elicit immune responses against twelve different pathways that are essential to tumor growth, survival and metastasis.HLA-A2+ is a required criteria for subject eligibility.

Conditions

  • Epithelial Ovarian, Tubal or Peritoneal Cancer

Interventions

BIOLOGICAL

tumor peptide vaccine

Cohort 1 low dose level of vaccine @ 0.3 mg administered as x1 weekly injection given intradermally/subcutaneously into site assigned( same limb) for total number of study vaccine injections = 6.

BIOLOGICAL

tumor peptide vaccine

Cohort 2 high dose vaccine @ 1 mg administered as x1 weekly injection given intradermally/subcutaneously into site assigned( same limb) for total number of study vaccine injections = 6.

Sponsors & Collaborators

  • Immunotope

    collaborator INDUSTRY

  • Michael Morse, MD

    lead OTHER

Principal Investigators

  • Michael Morse, MD · Duke University

  • Angeles A Secord, MD · Duke University

  • Ramila Philip, PhD · Immunotope

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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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 NCT00437502 on ClinicalTrials.gov