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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00478452
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : August 18, 2017
Fox Chase Cancer Center
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

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 or disease Intervention/treatment Phase
Ovarian Cancer Biological: DC-Ova Biological: DC Ova with Cyclophosphamide Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Experimental: DC Ova
DC Ova vaccine administered day 2 and week 3,6,9
Biological: DC-Ova
Active Comparator: DC Ova with Cyclophosphamide
Cyclophosphomide administered at day 0 prior to administration of DC Ova vaccine administered day 2 and week 3,6,9
Biological: DC Ova with Cyclophosphamide

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00478452

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

Additional Information:
Responsible Party: University of Pennsylvania Identifier: NCT00478452     History of Changes
Other Study ID Numbers: 707800
UPCC 01803 ( Other Identifier: CTSRMC )
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists