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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT 2007-007734-19 | |||
| CCMO NL21308.000.07 |
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| Name | Class |
|---|---|
| ISA Pharmaceuticals B.V. | INDUSTRY |
| Dutch Cancer Society | OTHER |
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The purpose of this study is to determine whether the addition of cyclophosphamide to the treatment with the p53-SLP vaccine improves clinical efficacy and immunogenicity of the p53-SLP vaccine in ovarian cancer patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P53-SLP vaccine | Drug | The P53-SLP vaccine is a vaccine consisting of a total of 10 long (30 amino acids on average length) peptides, covering the p53 protein sequence from amino acid 70 to 251, combined with Montanide ISA51 an adjuvant with a sustained dendritic cell activating ability. Patients will be immunised subcutaneously with the peptide vaccine four times with a three week interval (300μg/peptide). | ||
| Cyclophosphamide | Drug | Two days prior to each peptide vaccination, patients will receive 300mg/m2 cyclophosphamide i.v. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical responses to the p53 synthetic long peptide vaccine preceded by cyclophosphamide will be assessed by measurement of serum CA-125 levels and CT-scan. | day 105 - 126 after first gift of cyclophosphamide | |
| Immunogenicity will be evaluated by assessing induction and frequency of p53-specific T cells by proliferation and IFN-γ ELISPOT. | after fourth immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the vaccine preceded by cyclophosphamide will be assessed by monitoring the incidence and severity of adverse events using Common Terminology Criteria for Adverse Events v3.0. | durante study |
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Inclusion Criteria:
ASAT < 100 U/l; ALAT < 113 U/l; PT 9-12 seconds; APTT 23-33 seconds; creatinine < 135 μmol/l; WBC > 3.0 x 109/L; platelets > 100 x 109/L; hemoglobin > 6.0 mmol/l.
- Adequate venous access for blood collection and i.v. administration of cyclophosphamide.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H. W. Nijman, MD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Groningen | Groningen | Provincie Groningen | 9700 RB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19188184 | Background | Speetjens FM, Kuppen PJ, Welters MJ, Essahsah F, Voet van den Brink AM, Lantrua MG, Valentijn AR, Oostendorp J, Fathers LM, Nijman HW, Drijfhout JW, van de Velde CJ, Melief CJ, van der Burg SH. Induction of p53-specific immunity by a p53 synthetic long peptide vaccine in patients treated for metastatic colorectal cancer. Clin Cancer Res. 2009 Feb 1;15(3):1086-95. doi: 10.1158/1078-0432.CCR-08-2227. | |
| 17415711 |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C000609547 | p53 synthetic long peptide vaccine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Background |
| Lambeck A, Leffers N, Hoogeboom BN, Sluiter W, Hamming I, Klip H, ten Hoor K, Esajas M, van Oven M, Drijfhout JW, Platteel I, Offringa R, Hollema H, Melief K, van der Burg S, van der Zee A, Daemen T, Nijman H. P53-specific T cell responses in patients with malignant and benign ovarian tumors: implications for p53 based immunotherapy. Int J Cancer. 2007 Aug 1;121(3):606-14. doi: 10.1002/ijc.22710. |
| 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 |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |