DCVax-L Vaccination With CD3/CD28 Costimulated Autologous T-Cells for Recurrent Ovarian or Primary Peritoneal Cancer

Subjects with recurrent epithelial ovarian carcinoma or primary peritoneal cancer, who have previously undergone vaccination in clinical study UPCC-11807 with DCVax-L, an autologous vaccine with DC loaded in vitro with autologous tumor lysate. Phase I Subjects enrolled in this study will receive leukapheresis; followed by cyclophosphamide/fludarabine-induced lymphodepletion; followed by adoptive transfer of ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells; followed by a single DCVax-L vaccination, to establish feasibility and safety of this approach. Primary Objectives of Phase I To determine the feasibility and safety of administering vaccine-primed, ex vivo CD3/CD28-costimulated autologous peripheral blood T cells in combination with DCVax-L vaccination, following lymphodepletion with high dose cyclophosphamide/fludarabine. Phase II Twenty-two additional subjects will be randomized to receive either: * ARM-IIA: maintenance DCVax-L vaccination, in combination with oral metronomic cyclophosphamide, or * ARM-IIB: leukapheresis, followed by cyclophosphamide/fludarabine-induced lymphodepletion, followed by adoptive transfer of ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells, followed by maintenance DCVax-L vaccination, plus oral metronomic cyclophosphamide. Primary Objective of Phase II To assess the distribution of progression-free survival at 6 months for patients treated with maintenance DCVax-L vaccination plus oral metronomic cyclophosphamide as well as patients treated with ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells after lymphodepletion with high dose cyclophosphamide / fludarabine, followed by DCVax-L boost vaccination and metronomic oral cyclophosphamide.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* Previous participation in UPCC 11807 (A Phase I Clinical Trial of Autologous Dendritic Cell Vaccine Loaded with Autologous Tumor Cell Lysate for Recurrent Ovarian or Primary Peritoneal Cancer)
* PS \< 2
* Subject must have tumor lysate sufficient to prepare at least 4 DCVax-L vaccines
* 18 years of age or older
* Life expectancy \> 4 months
* Signed Informed Consent
* Normal organ and bone marrow function defined by:
* ANC ≥ 1,000/μl
* Platelets \>100,000/μl
* AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal
* Bilirubin \<2.0 mg/dL unless secondary to bile duct blockage by tumor
* Creatinine \<1.5 X the upper limit of normal

Exclusion Criteria:

* Subjects with the following:
* known brain metastases
* renal insufficiency
* liver failure
* organ allograft
* known autoimmune/collagen vascular disorders
* pregnant or breast feeding
* non-healing wounds, ulcers, or bone fractures
* positive for serum anti-Yo (cdr2) antibodies
* uncontrolled hypertension
* Myocardial infarction or unstable angina within 6 months prior to registration
* New York Heart Association (NYHA) Grade II or greater congestive heart failure