Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Five cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide or in combination with intravenous Bevacizumab, cyclophosphamide and aspirin. Study duration is 24 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCDC | Biological | OCDC,an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with either intravenous Daclizumab, or with a combination of Daclizumab and intravenous Bevacizumab. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version3.0). All toxicities observed within 30 days of last vaccination will be included. | 30 days of last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response | Clinical Response will be determined by RECIST criteria. Response rate is the proportion of patients that achieve CR or PR. | |
| Dose limiting toxicity | Dose-limiting toxicity is defined as: any Grade 3 or higher allergic, autoimmune or injection site reaction or any Grade 4 hematologic or non-hematologic toxicity (except fever). |
Not provided
Inclusion Criteria Subject has recurrent ovarian (including low malignant potential), fallopian tube, or primary peritoneal cancer.
EXCLUSION CRITERIA
Subject for whom tumor lysate does not meet release criteria
Subject has a positive serum Yo antibody
Subject whose groins are not accessible.
Subject has a chronic or acute hepatitis C infection. Subject with an old infection that has cleared may be included.
Subject has a chronic or acute hepatitis B infection. Subject with an old infection that has cleared may be included.
Subject has positive test result at the screening visit for one or more of the following:
Subject requires or is likely to require more than a two-week course of corticosteroids for intercurrent illness. Subject must complete the course of corticosteroids 2 weeks before screening to meet eligibility.
Subject has renal insufficiency as defined by a serum creatinine greater than 2.2 mg/dl or BUN greater than 40 mg/dl. Note: If creatinine is greater than 1.5 x ULN, creatinine clearance must be greater than 60ml/min.
Subject has proteinuria greater than 3.5 gm over 24 hrs are not eligible for the study (cohort 2 only)
Subject with liver failure as defined by a serum total bilirubin greater than 2.0 and/or serum transaminases greater than 3X the upper limits of normal.
Subject has hematopoietic failure at baseline as defined by one of the following:
Subject has any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
Subject has a serious, non-healing wound, ulcer, or bone fracture.
Subject has a clinically significant cardiovascular disease including:
Uncontrolled hypertension;
Myocardial infarction or unstable angina within 6 months prior to enrollment
New York Heart Association (NYHA) Grade II or greater congestive heart failure
Subject has a grade II or greater peripheral vascular disease.
Subject has a clinically significant peripheral artery disease, e.g., those with claudication, within 6 months.
Subject has any underlying conditions, which would contraindicate therapy with study treatment (or allergies to reagents used in this study).
Subject has organ allografts.
Subject is receiving medication(s) that might affect immune function. Use of H2 antagonists are prohibited as are all antihistamines five days before and five days after each injection of study vaccine. However, NSAIDS including COX-2 inhibitors, acetaminophen or aspirin are permitted.
Subject has clinical symptoms or signs of partial or complete gastrointestinal obstruction or who require parenteral hydration and/or nutrition (For cohort 2, 3, 4 and 5).
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ovarian Cancer Research Center | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22082029 | Derived | Chiang CL, Maier DA, Kandalaft LE, Brennan AL, Lanitis E, Ye Q, Levine BL, Czerniecki BJ, Powell DJ Jr, Coukos G. Optimizing parameters for clinical-scale production of high IL-12 secreting dendritic cells pulsed with oxidized whole tumor cell lysate. J Transl Med. 2011 Nov 14;9:198. doi: 10.1186/1479-5876-9-198. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Immune Response Immune Response | Immune response will be evaluated by IFN-g ELISPOT analysis of tumor-reactive T cells, and in HLAA2+ subjects, by tetramer analysis of Her-2 specific T cells in peripheral blood. Response is defined by a 3 fold increase relative to pre-vaccination. |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |