- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02277392
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
September 26, 2018 updated by: Abramson Cancer Center of the University of Pennsylvania
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
Study Overview
Status
Withdrawn
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Adverse Events
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
October 27, 2014
First Submitted That Met QC Criteria
October 27, 2014
First Posted (Estimate)
October 29, 2014
Study Record Updates
Last Update Posted (Actual)
September 27, 2018
Last Update Submitted That Met QC Criteria
September 26, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 02814
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedStage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian... and other conditionsUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Stage IIA Fallopian Tube Cancer | Stage IIA Ovarian Cancer | Stage IIB Fallopian Tube Cancer | Stage IIB Ovarian Cancer | Stage IIC Fallopian Tube Cancer | Stage IIC Ovarian Cancer | Stage IIIA Fallopian... and other conditionsUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); Sanofi Pasteur, a Sanofi CompanyCompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIA Fallopian Tube Cancer | Stage IIB Fallopian Tube Cancer | Stage IIC Fallopian Tube Cancer | Stage... and other conditionsUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIA Fallopian Tube Cancer | Stage IIB Fallopian Tube Cancer | Stage IIC Fallopian Tube Cancer | Stage... and other conditions
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian Tube Cancer | Stage IIIB Ovarian Cancer | Stage IIIB Primary Peritoneal Cancer | Stage IIIC Fallopian Tube Cancer | Stage IIIC Ovarian Cancer | Stage IIIC Primary Peritoneal Cancer and other conditionsUnited States
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)WithdrawnRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Malignant Ovarian Clear Cell Tumor | Stage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian Tube Cancer | Stage IIIB Ovarian... and other conditions
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)WithdrawnStage IIIA Fallopian Tube Cancer | Stage IIIA Ovarian Cancer | Stage IIIA Primary Peritoneal Cancer | Stage IIIB Fallopian Tube Cancer | Stage IIIB Ovarian Cancer | Stage IIIB Primary Peritoneal Cancer | Stage IIIC Fallopian Tube Cancer | Stage IIIC Ovarian Cancer | Stage IIIC Primary Peritoneal Cancer and other conditions
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National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIB Fallopian Tube Cancer | Stage IIIC Fallopian Tube Cancer and other conditionsCanada
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