Autologous T-Cells Combined With Autologous OC-DC Vaccine in Ovarian Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor: Abramson Cancer Center at Penn Medicine
Study ID: NCT01312376
Phase: PHASE1
Status: Terminated

Conditions

Fallopian Tube Cancer
Ovarian Carcinoma
Primary Peritoneal Cancer

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

OC-DC vaccine — BIOLOGICAL
All subjects will receive a dose of 5-10 million cells of OC-DC intradermally
Bevacizumab — DRUG
Patients will start receiving Bevacizumab at 15 mg/kg starting Day 30 and every 4 weeks thereafter until end of study.
cyclophosphamide 300 mg/m2/d for 3 days — DRUG
All subjects will receive a single course of outpatient lympho-depleting chemotherapy with intravenous cyclophosphamide for 300 mg/m2/d for 3 days.
fludarabine 30 mg/m2/d for 3 days — DRUG
All subjects will receive a single course of outpatient lympho-depleting chemotherapy with intravenous fludarabine 30 mg/m2/d for 3 days
ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells — DRUG
All subjects will receive a single intravenous infusion of ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T-cells at the starting dose of 10-15 x 109 (10-15 billion) T-cells with escalating doses in cohort 2 and 3.

Study Details

This is a phase-I clinical trial to determine the feasibility and safety of Cyclophosphamide/Fludarabine Lymphodepletion and an immunomodulatory combination of Interferon-alpha Bevacizumab and Aspirin followed by adoptive transfer of vaccine-primed ex vivo CD3/CD28-costimulated peripheral blood autologous T cells and vaccination with whole tumor vaccine administered intradermally in combination with Bevacizumab in patients with recurrent ovarian cancer fallopian tube or primary peritoneal cancer. (Funding Source - FDA OOPD)