Brief Title
Dendritic Cell Vaccine for High Risk Ovarian Cancer Patients
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
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.
Detailed Description
HLA-A2+ subjects with stage II-IV who have completed chemotherapy and are in clinical
remission or patients with stage I-IV advanced ovarian cancer or primary serous peritoneal
cancer in clinical remission post treatment for disease recurrence occurring after a
progression-free interval of at least two years will be eligible. Patients will be evaluated
by standard imaging techniques. Patients will be randomized to cyclophosphamide 300 mg/m2
(arm 2) or no cyclophosphamide (arm 1). All subjects will receive intradermal injections of
DC on day 2 and on week 3, 6, and 9 (+ 3 days). All subjects will undergo leukocyte apheresis
at study enrollment and at week 10, which is the end of active study intervention. All study
arm 1 and 2 patients (without prior vaccination with the current season's vaccine) will
receive a single dose of trivalent killed influenza vaccine, and a single dose of Prevnar
pneumococcal vaccine on the day they receive their first intradermal injections of DC on day
2.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
To assess the immunogenicity (with or without prior cyclophosphamide administration) of IDD-6, a peptide-loaded matured DC vaccine.
Condition
Ovarian Cancer
Intervention
DC-Ova
Study Arms / Comparison Groups
DC Ova
Description: DC Ova vaccine administered day 2 and week 3,6,9
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
14
Start Date
August 2005
Completion Date
August 2008
Primary Completion Date
August 2008
Eligibility 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Christina Chu, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00478452
Organization ID
707800
Secondary IDs
UPCC 01803
Responsible Party
Sponsor
Study Sponsor
University of Pennsylvania
Collaborators
Fox Chase Cancer Center
Study Sponsor
Christina Chu, MD, Principal Investigator, University of Pennsylvania Hospital
Verification Date
October 2019