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

• Status: Terminated
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Treatments: Bevacizumab; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Vaccines

Criteria

Inclusion Criteria:

• Subjects who have received at least one vaccine under protocol UPCC-19809 or UPCC-29810.

• ECOG performance status 0 or 1.

• Subject has sufficient vaccine (2 vaccine doses are sufficient)

• Must be at least 4 weeks post-operative

• Blood coagulation parameters: PT such that international normalized ratio (INR) is less than1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin for management of venous thrombosis including pulmonary thromboembolus) and a PTT less than1.2 times the upper limit of normal.

• Subject must be 18 years of age or older.

• Life expectancy of greater than 4 months.

• Normal organ and bone marrow function as defined by: Absolute neutrophil count greater than 1,000/microliter, Platelets greater than 100,000/microliter, Hematocrit greater than 30%, AST (SGOT)/ALT(SGPT) less than 2.5 X institutional upper limit of normal, Bilirubin less than 2.0 mg/dL unless secondary to bile duct blockage by tumor, and Creatinine less than 1.8 mg/dL

Exclusion Criteria:

• Subjects who require or are likely to require more than a two-week course of corticosteroids for intercurrent illness. Subjects must complete therapy prior to enrollment. Topical corticosteroids should be stopped at least 2 weeks prior to enrollment and systemic corticosteroids should be stopped at least 4 weeks prior to enrollment.

• Subjects with any acute infection that requires specific therapy. Acute therapy must have been completed at least seven days prior to study enrollment

• Subjects with any underlying conditions, which would contraindicate therapy with, study treatment (or allergies to reagents used in this study).

• Subjects with prior history or symptoms suggestive of partial or complete bowel obstruction.

• Subjects receiving class III antiarrythmic medications.

• Subjects receiving medications that might affect immune function. Additionally, H2 blockers are excluded, as are all antihistamines five days before and five days after each injection of study drug. NOTE: The following are exceptions: Proton pump Inhibitors (PPIs), NSAIDS including COX-2 inhibitors, acetaminophen.

• Subjects who are allergic to Aspirin are excluded

• Development of clinically significant co morbid disease that would contraindicate study therapy or confuse interpretation of study results.

• Subjects with a History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess.

• Subjects with evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.