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| ID | Type | Description | Link |
|---|---|---|---|
| UPCC 01803 | Other Identifier | CTSRMC |
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| Name | Class |
|---|---|
| Fox Chase Cancer Center | OTHER |
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This is a randomized Phase I/II study designed to assess the induction of an anti-tumor immune response; the effect of cyclophosphamide on the vaccine; and to assess safety in subjects with advanced ovarian cancer or primary serous peritoneal cancer given a multivalent DC vaccine, with or without a single dose of cyclophosphamide.
Potential benefit may range from no direct benefit to the study participants to stimulation of the subject's own immune system to attack ovarian cancer to prevent relapse.
HLA-A2+ subjects with stage II-IV who have completed chemotherapy and are in clinical remission or patients with stage I-IV advanced ovarian cancer or primary serous peritoneal cancer in clinical remission post treatment for disease recurrence occurring after a progression-free interval of at least two years will be eligible. Patients will be evaluated by standard imaging techniques. Patients will be randomized to cyclophosphamide 300 mg/m2 (arm 2) or no cyclophosphamide (arm 1). All subjects will receive intradermal injections of DC on day 2 and on week 3, 6, and 9 (+ 3 days). All subjects will undergo leukocyte apheresis at study enrollment and at week 10, which is the end of active study intervention. All study arm 1 and 2 patients (without prior vaccination with the current season's vaccine) will receive a single dose of trivalent killed influenza vaccine, and a single dose of Prevnar pneumococcal vaccine on the day they receive their first intradermal injections of DC on day 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DC Ova | Experimental | DC Ova vaccine administered day 2 and week 3,6,9 |
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| DC Ova with Cyclophosphamide | Active Comparator | Cyclophosphomide administered at day 0 prior to administration of DC Ova vaccine administered day 2 and week 3,6,9 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-Ova | Biological |
| ||
| DC Ova with Cyclophosphamide |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the immunogenicity (with or without prior cyclophosphamide administration) of IDD-6, a peptide-loaded matured DC vaccine. | Immunogenicity will be assessed by determining the frequency of specific HLA A -restricted T cells following vaccination with her2/neu, hTERT and PADRE -loaded DC | 24 months |
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Inclusion Criteria:
Disease Criteria. Patients will be eligible:
Patients with adequate organ function as measured by:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Chu, MD | University of Pennsylvania Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| Label | URL |
|---|---|
| University of Pennsylvania Abramson Cancer Center Web Line | View source |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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Patients will be randomized to cyclophosphamide 300 mg/m2 (arm 2) or no cyclophosphamide (arm 1). All subjects will receive intradermal injections of DC on day 2 and on week 3, 6, and 9 (+ 3 days). All subjects will undergo leukocyte apheresis at study enrollment and at week 10, which is the end of active study intervention. All study arm patients (1 and 2) will receive a single dose of trivalent killed influenza vaccine, and a single dose of Prevnar pneumococcal vaccine on the day they receive their first intradermal injections of DC on day 2.
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| 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 |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |