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A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA-51) as Consolidation Following Optimal Debulking and Systemic Chemotherapy for Women With Advanced Stage Ovarian, Tubal or Peritoneal Cancer
This study is currently recruiting participants.
Verified by Duke University, August 2008
Sponsors and Collaborators: Duke University
Immunotope
Information provided by: Duke University
ClinicalTrials.gov Identifier: NCT00437502
  Purpose

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.


Condition Intervention Phase
Epithelial Ovarian, Tubal or Peritoneal Cancer
Biological: OCPM Immunotherapeutic Vaccine
Phase I

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor Montanide ISA 51
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title: A Phase I Study of Ovarian Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA-51) as Consolidation Following Optimal Debulking and Systemic Chemotherapy for Women With Advanced Stage Ovarian, Tubal, or Peritoneal Cancer

Further study details as provided by Duke University:

Detailed Description:

The primary endpoint will be to determine the safety and feasibility of administering ovarian cancer peptides to women who have undergone debulking surgery and systemic chemotherapy, with the secondary objectives of evaluating immune response as measured by ELISPOT to the immunizations, to compare the immune response as measured by ELISPOT achieved by the two different dosing strategies and to assess disease relapse survival. Two cohorts of 9 patients each will be treated with different doses of the OCPM vaccine. They will receive the peptide vaccine subcutaneously on weeks 0,1,2,3,5 and6 and then receive the immunizations every 1 month for 6 months or disease recurrence. The first 9 patients will be entered into the first cohort; if 1 or fewer patients experience Dose-limiting toxicity (DLT) then the next 9 will be enrolled into the second cohort. DLT is defined as any Grade 3 or greater hematologic or non-hematologic toxicity or autoimmune disease (except for fever, skin reaction, or alopecia which would be grade 4) occurring at any time from the first immunization until 30 days after the last immunization. Toxicity will be assessed at each dose level using CTC toxicity criteria. Ovarian cancer peptide-specific immune response will be measured by ELISpot. Time to disease relapse will be based on composite assessment of clinical signs, objective exam findings, radiologic imaging, and CA125 results. A dosing scheme will be considered safe if <1 of the first 9 subjects treated at a dose level experience DLT (as described above). A subject will be considered evaluable for safety if treated with at least one immunization. A T cell response will be considered positive by ELISpot if: the mean number of spots in six wells with antigen exceeds the number of spots in six control wells by 10 and the difference between single values of the six wells containing antigen and the six control wells is statistically significant at a level of p ≤ 0.05 using Student's t test.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Must be HLA-A2+ patients with histologically confirmed, stage III-IV epithelial ovarian, tubal, or peritoneal cancer who have undergone optimal debulking and had a complete clinical response to front-line platin/taxane based chemotherapy.

  • Subjects must have received front-line platin compound and taxane chemotherapy following primary surgical resection. Front-line treatment can include up to 12 cycles of treatment.Subjects must receive the first dose of study medication at least 4 weeks and up to 6 months since completing their last dose of front-line chemotherapy.A complete clinical response defined as: no evidence of disease on pysical exam,CT imaging scans of the abdomen and pelvis, chest x-ray and a CA-125 below the upper limit of normal.

Exclusion Criteria:

  • History of autoimmune disease, serious intercurrent chronic or acute illness, active hepatitis, serologic evidence for HIV, splenectomy, or be receiving steroid or immunosuppressive therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437502

Contacts
Contact: Nancy J Lee, RN 919-681-5595 Nancy.Lee@duke.edu
Contact: Liz Anderson, RN 919-668-5591or 6406 ander094@mc.duke.edu

Locations
United States, North Carolina
Duke Comprehensive Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Nancy Lee, RN     919-681-5595     Nancy.Lee@duke.edu    
Contact: Liz Anderson, RN     919-668-5591or 6406     ander094@mc.duke.edu    
Principal Investigator: Michael Morse, MD            
Sub-Investigator: Angeles Secord, MD            
Sponsors and Collaborators
Duke University
Immunotope
Investigators
Principal Investigator: Michael Morse, MD Duke University
Principal Investigator: Angeles A Secord, MD Duke University
Principal Investigator: Ramila Philip, PhD Immunotope
  More Information

Study ID Numbers: BB-IND 12605
Study First Received: February 19, 2007
Last Updated: August 13, 2008
ClinicalTrials.gov Identifier: NCT00437502  
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Immunotherapeutic vaccine
Ovarian cancer
epithelial ovarian cancer
tubal cancer
peritoneal cancer
immunotherapy

Study placed in the following topic categories:
Ovarian cancer
Ovarian Neoplasms
Digestive System Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Abdominal Neoplasms
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 15, 2009