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

Stopped early · Phase 1

Conditions studied: Ovarian Carcinoma, Fallopian Tube Cancer, Primary Peritoneal Cancer

In brief

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)

Key facts

Study ID

NCT01312376

Run by

Abramson Cancer Center at Penn Medicine

People needed

18

Starts

2011-03-01

Expected to finish

2019-01-01

Last updated by the study team

2020-04-24

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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