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

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Ovarian Cancer, Primary Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT00603460

Run by

University of Pennsylvania

People needed

0

Starts

2012-01-01

Expected to finish

2013-03-01

Last updated by the study team

2017-05-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pennsylania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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