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
- 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.
- Any one of the following conditions eliminates a patient from participating in this
- Prior malignancy (except basal cell or squamous cell skin cancer) within the past
- 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
- 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
- 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.