Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT00603460
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00603460
Study Brief:
Protocol Section:
NCT00603460