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TerminatedNCT01312376Updated Apr 24, 2020

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

A Phase 1 interventional study of OC-DC vaccine and Bevacizumab in Ovarian Carcinoma, Fallopian Tube Cancer and Primary Peritoneal Cancer, sponsored by Abramson Cancer Center at Penn Medicine. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-24.

Sponsored by Abramson Cancer Center at Penn Medicine · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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)

Read the detailed description

This is a phase-I clinical trial to determine the feasibility and safety of cyclophosphamide/fludarabine lymphodepletion and an immunomodulatory combination of Interferon-alpha (INF-a), 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 who previously underwent induction vaccination with whole tumor vaccine.

Subjects will receive T-lymphocytes infusion at a dose of 20 billion ± 20% cells for all patients. Subjects who cant meet target dose level can still enroll but will be analyzed separately.

Before T-cell infusion, all subjects will undergo lymphodepletion with a single course of outpatient high-dose lymphodepleting chemotherapy with intravenous cyclophosphamide (300 mg/m2/d for 3 consecutive Days) and intravenous fludarabine (30 mg/m2/d for 3 consecutive Days on Days -5 to -3).

Subjects enrolled in this study will receive an immunomodulatory cycle of (Bevacizumab and Aspirin) \~14 Days before apheresis (if they do not have a frozen apheresis product from a previous collection) and another cycle between apheresis and T-cell infusion (approx. from Day -20 through Day -7, (+/- 5 Days)). The immunomodulatory cycle will consist of the following: intravenous 10 mg/kg Bevacizumab on Day -35, and Day -20 (+/- 5 Days), and 325 mg Enteric Coated Aspirin orally starting Day -35 for 14 Days and starting on Day -20 for 14 Days. They will also receive three subcutaneous injections of Interferon-alpha (Intron®a 2b) (INF-a) (subjects will have the option to self administer Interferon-alpha and they will be provided instructions) at a dose of 5 MIU on Days -3, -2 and -1. EX vivo CD3/CD28-costimulated lymphocytes will be infused \~1-2 Days after last Day of interferon-alpha treatment, ideally on Day 0.

All subjects will receive a dose of 5-10 million cells of OC-DC vaccine intradermally, or OC-L (2.5-5x106 oxidized tumor cells admixed with Montanide ISA 51 VG) 2-3 Days post T-cell infusion and on Day 16-18. Subjects will start receiving Bevacizumab at 15 mg/kg and vaccine (if available) starting Day 30 and every 3 weeks thereafter until end of study. (Funding Source - FDA OOPD)

02

Conditions studied

  • Ovarian Carcinoma
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
03

In context

Fallopian Tube Neoplasms

720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.

This study's enrollment of 18 is below the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.

Browse Fallopian Tube Neoplasms studies →

Lead sponsor

Abramson Cancer Center at Penn Medicine is the lead sponsor of 446 studies on the registry; 86 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 14 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Interventions

  • BiologicalOC-DC vaccine

    All subjects will receive a dose of 5-10 million cells of OC-DC intradermally

  • DrugBevacizumab

    Patients will start receiving Bevacizumab at 15 mg/kg starting Day 30 and every 4 weeks thereafter until end of study.

  • Drugcyclophosphamide 300 mg/m2/d for 3 days

    All subjects will receive a single course of outpatient lympho-depleting chemotherapy with intravenous cyclophosphamide for 300 mg/m2/d for 3 days.

  • Drugfludarabine 30 mg/m2/d for 3 days

    All subjects will receive a single course of outpatient lympho-depleting chemotherapy with intravenous fludarabine 30 mg/m2/d for 3 days

  • Drugex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells

    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.

06

What researchers measure

Primary outcomes

  1. Dose Limiting Toxicity

    Dose limiting toxicity is defined as the occurrence of treatment-related adverse events.

    Time frame: 5 Years

Secondary outcomes

  1. Tumor response

    Tumor response will be estimated by measures of tumor burden and survival.

    Time frame: 5 years

07

Study locations

1 site
  • Abramson Cancer Center of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01312376
Lead sponsor
Abramson Cancer Center at Penn Medicine
Responsible party
Sponsor
First posted
Mar 10, 2011
Start date
Mar 2011
Primary completion
Oct 2015
Completion
Jan 2019
Last update
Apr 24, 2020

Study contacts

Janos Tanyi, MD
principal investigator · Abramson Cancer Center at Penn Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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