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| Name | Class |
|---|---|
| Ovarian Cancer Research Center | UNKNOWN |
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This is a randomized pilot trial to test the addition of 2 investigational agents, Montanide and poly-ICLC (a TLR3 agonist) to a backbone of autologous oxidized tumor cell lysate vaccine (OC-L) administered with GMCSF in subjects with primary epithelial ovarian, fallopian tube, or primary peritoneal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Subjects in ARM 1 will receive the vaccination with OC-L alone |
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| Arm 2 | Experimental | subjects in ARM 2 will receive vaccination with OC-L admixed with Montanide, |
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| Arm 3 | Experimental | subjects in ARM3 will receive vaccination with OC-L admixed with 1 mg poly-ICLC (Hiltonol) |
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| Arm 4 | Experimental | subjects in ARM 4 will receive vaccination with OC-L admixed with both Montanide and 1 mg poly-ICLC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OC-L | Biological |
| ||
| Montanide |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of Adverse Events | 3.5 years |
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Inclusion Criteria:
Exclusion Criteria:
Subject for whom tumor lysate does not meet release criteria
Subject has a positive serum Yo antibody (Does not need to be repeated if performed in the past)
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 > 2.2 mg/dl or BUN > 40 mg/dl. Note: If creatinine is greater than 1.5 x ULN, creatinine clearance must be greater than 60ml/min.
Subject has proteinuria > 3.5 gm over 24 hrs are not eligible for the study
Subject with liver failure as defined by a serum total bilirubin > 2.0 and/or serum transaminases > 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:
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
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ovarian Cancer Research Center | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000712049 | Monatide (IMS 3015) |
| C019531 | poly ICLC |
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|
| poly-ICLC (Hiltonol), | Other |
|
| D005184 |
| Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |