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As a follow-on study to NCT01416038, this study is designed to identify the optimal dosage of immunotherapeutic survivin vaccine DPX-Survivac and low dose oral cyclophosphamide. The combination treatment is being evaluated in a non-randomized, multi-cohort study as post-chemotherapy treatment for patients with late-stage ovarian, fallopian tube, or peritoneal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide |
|
| Cohort 2 | Experimental | 6 Doses DPX-Survivac (2 prime q3w, 4 boost q8w) Low dose cyclophosphamide |
|
| Cohort 3 | Experimental | 3 Doses DPX-Survivac (1 prime, 2 boost q8w) Low dose cyclophosphamide |
|
| Cohort 4 | Experimental | 5 Doses DPX-Survivac (2 prime q6w, 3 boost q6w) Low dose cyclophosphamide |
|
| Cohort 5 | Experimental | 5 Doses DPX-Survivac/DPX-Survivac(Aqueous) (2 prime q4w, 3 boost q4w) Low dose cyclophosphamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPX-Survivac | Biological | SubQ injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by adverse event reporting (CTCAE) | up to 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cell mediated immunity as measured by the antigen specific response in peripheral blood | up to 11 months | |
| Impact on residual tumour | Evaluated by standard of care radiology and CA-125 | up to 11 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University Hospital | Mineola | New York | 11501 | United States | ||
| Lenox Hill Hospital |
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| DPX-Survivac(Aqueous) | Biological | SubQ injection |
|
| Cyclophosphamide | Drug | PO BID |
|
| New York |
| New York |
| 10028 |
| United States |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| 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 |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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