Dendritic Cell Vaccine for High Risk Ovarian Cancer Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00478452
• Date of registration: 22/05/2007
• Primary sponsor: University of Pennsylvania
• Public title: Dendritic Cell Vaccine for High Risk Ovarian Cancer Patients DC-Ova
• Scientific 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
• Date of first enrolment: August 2005
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00478452
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Christina Chu, MD
• Affiliation: University of Pennsylvania Hospital

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Cancer

Intervention(s)

Biological: DC-Ova

Secondary ID(s)

707800

UPCC 01803

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fox Chase Cancer Center