Dendritic Cell Vaccine for High Risk Ovarian Cancer Patients (DC-Ova)

This study has been completed.
Sponsor:
Collaborator:
Fox Chase Cancer Center
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00478452
First received: May 22, 2007
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

This is a randomized Phase I/II study designed to assess the induction of an anti-tumor immune response; the effect of cyclophosphamide on the vaccine; and to assess safety in subjects with advanced ovarian cancer or primary serous peritoneal cancer given a multivalent DC vaccine, with or without a single dose of cyclophosphamide.

Potential benefit may range from no direct benefit to the study participants to stimulation of the subject's own immune system to attack ovarian cancer to prevent relapse.


Condition Intervention Phase
Ovarian Cancer
Biological: DC-Ova
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase I/II Pilot Study of the Immunogenicity of Cyclophosphamide With Peptide Pulsed Mature Dendritic Cells for Patients With Previously Treated Ovarian Epithelial or Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Estimated Enrollment: 24
Study Start Date: August 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • The following conditions must be met before a patient may be enrolled in the study.
  • Patients age 18 years of age and older.

Disease Criteria. Patients will be eligible:

  • If no clinical evidence of disease is present after diagnosis with stage III or
  • IV disease and completion of primary surgery and chemotherapy, or, if no clinical evidence of disease is present after completion of chemotherapy for a disease recurrence diagnosed after a progression-free interval of at least 2 years, for patients of any initial stage.or primary peritoneal carcinoma.
  • Complete clinical response = no evidence of tumor lesions shown by abdominal CT scan or MRI, chest Xray,and CA 125 level ≤ 35 UI/mL.
  • Time from completion of Chemotherapy will be no more than 6 months from last dose from initial diagnoses.
  • HLA-A2 positive (must be typed by molecular methods; all A2 alleles eligible).

Patients with adequate organ function as measured by:

  • Hematopoietic: WBC at least 3000/mm3; platelets at least 100,000/mm3, hemoglobin at least 10.0 g/dL (may be transfused).
  • Cardiac: Asymptomatic or, if symptomatic, then left ventricular ejection fraction at rest must be ≥50% or within the normal range of the institution. A cardiology clearance will be required for LV ejection fraction <50%.
  • Hepatic: SGOT within 2x normal range and total bilirubin ≤ 2.0 mg/dL.
  • Renal: Serum creatinine ≤2.0 mg/dL
  • Adequate performance status > 80% (Karnofsky) or ECOG 0-2
  • Written informed consent conforming to institutional guidelines.
  • Life expectancy > 6 months and absence of co-existing medical problems which would preclude participation in the judgment of the principal investigator.

Exclusion Criteria:

  • Any one of the following conditions eliminates a patient from participating in this protocol.
  • Prior malignancy (except basal cell or squamous cell skin cancer) within the past five years.
  • Presence of active Central Nervous System disease.
  • Serious systemic disease.
  • Active bacterial, viral or fungal infections.
  • Chemotherapy, biologic therapy or radiation therapy less than 4 weeks prior to study entry.
  • History of active autoimmunity or immunosuppression.
  • Use of immunosuppressive drugs within 4 weeks prior to study entry or anticipated use of immunosuppressive agents.
  • Patients with tumors of low malignant potential (borderline tumors) will not be eligible.
  • Seropositivity for HIV, HTLV-1, or HTLV-2.
  • Prior Influenza vaccination with the current vaccine will exclude patient from receiving protocol-specified influenza vaccine but will not exclude participation with the other aspects of the protocol. Each year's vaccine supply generally becomes available in October. Patients with a history of serious hypersensitivity to eggs, previous influenza vaccine or its components, will not receive influenza vaccine, but may continue to participate in other aspects of the protocol. Patients with a history of serious hypersensitivity to the Prevnar vaccine, its components, or diptheria toxoid will not receive the Prevnar vaccine, but may continue to participate in other aspects of the protocol.
  • Pregnant or breast feeding subjects.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478452

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Fox Chase Cancer Center
Investigators
Principal Investigator: Christina Chu, MD University of Pennsylvania Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Christina Chu, MD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00478452     History of Changes
Other Study ID Numbers: 707800, UPCC 01803
Study First Received: May 22, 2007
Last Updated: August 25, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014