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Ovarian, Fallopian Tube and Peritoneal CancerPhase 1NCT02277392

A Phase-I, Dose Escalation Study of Recombinant Human Interleukin-18 (Sb-485232) Combined With Adoptive Transfer of Vaccine-Primed CD3/CD28-Costimulated Autologous T-Cells Following Lymphodepletion for Adult Patients With Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer

A Phase 1 study testing Vaccine---primed, CD3/CD28---costimulated autologous peripheral blood T---cells and SB---485232 (Human recombinant Interleukin---18) in people with Ovarian, Fallopian Tube and Peritoneal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a phase-I, dose escalation study to assess the safety and biological activity of cyclophosphamide/fludarabine lymphodepletion followed by adoptive transfer of vaccine-primed, ex vivo CD3/CD28-costimulated peripheral blood autologous T-cells, and recombinant human interleukin-18 (SB-485232, IL-18) treatment in… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Vaccine---primed, CD3/CD28---costimulated autologous peripheral blood T---cells and SB---485232 (Human recombinant Interleukin---18)
Type of treatment
Vaccines
How many people
0 participants
Where
1 siteUnited States
Study dates
Sep 2014to Jun 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female greater than or equal to 18 years of age.
  • Histologically confirmed diagnosis of epithelial cancer. Subject must have a measurable disease for enrollment consideration
  • Subjects who have received at least one vaccine under protocol UPCC-19809 or UPCC-29810
  • Predicted life expectancy of greater than or equal to 4 months.
  • ECOG performance status 0 or 1.
  • Must be at least 4 weeks post-operative
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  • No chemotherapy, immunotherapy, hormonal therapy, or biological therapy for cancer, radiotherapy, or surgical procedures (except for minor surgical procedures) within four weeks before beginning treatment with SB-485232 (six weeks for nitrosoureas and mitomycin C). Subjects must have recovered from toxicities (incurred as a result of previous therapy) sufficiently to be entered into a Phase I study.
  • Blood coagulation parameters: PT such that international normalized ratio (INR) is less than or equal to 1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin or anticoagulants for management of venous thrombosis including pulmonary thrombo-embolus) and a PTT less than 1.5 times the upper limit of normal.
  • A signed and dated written informed consent form is obtained from the subject. - The subject is able to understand and comply with protocol requirements, timetables, instructions and protocol-stated restrictions.
  • Normal organ and bone marrow function as defined by: - Absolute neutrophil count greater than 1,000/ul - Platelets greater than 100,000/ul - Hematocrit greater than or equal to 30 percent - 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 - Creatinine less than1.8 mg/dL

Who cannot join

  • Significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or autoimmune conditions that in the opinion of the investigator places the subject at an unacceptable risk as participant in this trial.
  • Subjects with any severe concurrent disease or condition, including significant active autoimmune diseases such as rheumatoid arthritis, which in the judgment of the principal investigator would make the subject inappropriate for study participation.
  • 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 or severe or uncontrolled that requires systematic antibiotic 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).
  • Women who are pregnant or are breast-feeding.
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  • Subject has positive test result at the screening visit for one or more of the following: HTLV-1/2 and/or Anti-HIV 1 Antibody (a-HIV-1).
  • 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 or Enteric Coated Aspirin.
  • Subjects who are positive for serum anti-Yo (cdr2) antibodies are not eligible (Yo antibody does not need to be repeated if performed in the past).
  • Subjects receiving class III antiarrythmic medications.
  • Subjects with any serious medical or psychiatric disorder that would interfere with subject safety or informed consent.
  • Psychological,familial, sociological, or geographical conditions that do not permit compliance with the protocol.
  • Known leptomeningeal disease or evidence of prior or current metastatic brain disease.
  • Any investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of SB-485232.
  • Subject does not have measurable disease.
  • Subject has no tissue from UPCC19809 EOS biopsy and unwilling to undergo screening biopsy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

This is a phase-I, dose escalation study to assess the safety and biological activity of cyclophosphamide/fludarabine lymphodepletion followed by adoptive transfer of vaccine-primed, ex vivo CD3/CD28-costimulated peripheral blood autologous T-cells, and recombinant human interleukin-18 (SB-485232, IL-18) treatment in adult patients with recurrent, Stage III or IV ovarian cancer, fallopian tube or primary peritoneal cancer who previously underwent induction vaccination with whole tumor vaccine

Being tested
Vaccine---primed, CD3/CD28---costimulated autologous peripheral blood T---cells, SB---485232 (Human recombinant Interleukin---18)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaccine---primed, CD3/CD28---costimulated autologous peripheral blood T---cellsBiological

  • SB---485232 (Human recombinant Interleukin---18)Biological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Adverse Events

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02277392
Sponsor's protocol ID
UPCC 02814
Status last verified
Jul 2018
First submitted
27 Oct 2014
Last updated
27 Sep 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vaccine---primed, CD3/CD28---costimulated autologous peripheral blood T---cells and SB---485232 (Human recombinant Interleukin---18) in people with Ovarian, Fallopian Tube and Peritoneal Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02277392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.

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