DCVax-L Vaccination With CD3/CD28 Costimulated Autologous T-Cells for Recurrent Ovarian or Primary Peritoneal Cancer
Launched by UNIVERSITY OF PENNSYLVANIA · Jan 16, 2008
Trial Information
Current as of June 09, 2025
Withdrawn
Keywords
ClinConnect Summary
Description of treatment for Phase I:
* Patients will be offered, if medically indicated, tumor resection or needle aspiration of malignant effusion in order to make additional doses of DCVax-L vaccine.
* If subjects have not received DCVax-L vaccination within the last 3-4 weeks, and if DCVax-L is available, subjects have the option of receiving one dose of DCVax-L after enrolment, to boost the frequency of vaccine-primed T cells.
* Subjects will receive a single course of outpatient lymphodepleting chemotherapy with intravenous cyclophosphamide (300 mg/m2/d for 3 days) and intravenous fl...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Previous participation in UPCC 11807 (A Phase I Clinical Trial of Autologous Dendritic Cell Vaccine Loaded with Autologous Tumor Cell Lysate for Recurrent Ovarian or Primary Peritoneal Cancer)
- • PS \< 2
- • Subject must have tumor lysate sufficient to prepare at least 4 DCVax-L vaccines
- • 18 years of age or older
- • Life expectancy \> 4 months
- • Signed Informed Consent
- * Normal organ and bone marrow function defined by:
- • ANC ≥ 1,000/μl
- • Platelets \>100,000/μl
- • AST(SGOT)/ALT(SGPT) \< 2.5 X institutional upper limit of normal
- • Bilirubin \<2.0 mg/dL unless secondary to bile duct blockage by tumor
- • Creatinine \<1.5 X the upper limit of normal
- Exclusion Criteria:
- * Subjects with the following:
- • known brain metastases
- • renal insufficiency
- • liver failure
- • organ allograft
- • known autoimmune/collagen vascular disorders
- • pregnant or breast feeding
- • non-healing wounds, ulcers, or bone fractures
- • positive for serum anti-Yo (cdr2) antibodies
- • uncontrolled hypertension
- • Myocardial infarction or unstable angina within 6 months prior to registration
- • New York Heart Association (NYHA) Grade II or greater congestive heart failure
About University Of Pennsylvania
The University of Pennsylvania, a prestigious Ivy League institution located in Philadelphia, is renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and cutting-edge facilities to conduct innovative studies across various therapeutic areas. With a focus on translating scientific discoveries into clinical applications, the University of Pennsylvania fosters collaborations among leading researchers, clinicians, and industry partners, ensuring rigorous trial design and adherence to ethical standards. Through its dedication to excellence in research and education, the university plays a pivotal role in shaping the future of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Philadelphia, Pennsylvania, United States
Patients applied
Trial Officials
George Coukos, M.D., Ph.D.
Principal Investigator
University of Pennsylvania
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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