E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This is an uncontrolled, mono-centre, phase II single dose trial for patients with ovarian cancer, who have a rising serum tumor marker CA-125 after previous treatment (surgery and platinum based chemotherapy), to determine the clinical effectiveness of a p53 synthetic long peptide vaccine preceded by the administration of cyclophosphamide. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033128 |
E.1.2 | Term | Ovarian cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
A) To improve the clinical effectiveness of the p53 synthetic long peptides vaccine in Montanide ISA51 by administration of low dose cyclophosphamide prior to immunisation. B) To improve immunogenicity of the p53 synthetic long peptides vaccine in Montanide ISA51 by administration of low dose cyclophosphamide prior to immunisation
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of the p53 synthetic long peptide vaccine in combination with a defined adjuvant with known mode of action (Montanide ISA51) when preceded by administration of low dose cyclophosphamide. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Written informed consent. -Histological proven epithelial ovarian carcinoma -At least 4 weeks after termination of the last course of chemotherapy. -Rising CA-125 serum levels after “first line” treatment and no measurable disease according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria, or Rising CA-125 serum levels after “first line” treatment with measurable disease according to the RECIST (Response Evaluation Criteria in Solid Tumours) criteria, but not willing or otherwise not fit to receive “second line” chemotherapy. -Age 18 years or older, and an life expectancy of at least 3 months -Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial -Performance status 0 to 2 (WHO scale). -Adequate hepatic, renal, and bone marrow function as defined: 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.
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E.4 | Principal exclusion criteria |
-Pregnancy and / or breast feeding. -(A)symptomatic cystitis -Other malignancies (previous or current), except basal or squamous cell carcinoma of the skin. -Immunosuppressive agents, except for topical and inhalation corticosteroids. -Prior therapy with a biological response modifier. -Participation in any other trial with an investigational drug. -Any other major disease that may interfere with the conduct of the study (e.g. uncontrolled hypertension, severe and/or unstable heart disease, neurological and psychiatric disorders). -Signs or symptoms of CNS metastases. -Known substance abuse (drug or alcohol).
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E.5 End points |
E.5.1 | Primary end point(s) |
A) Clinical responses to the p53 synthetic long peptide vaccine preceded by low-dose cyclophosphamide will be assessed by measurement of serum CA-125 levels and CT-scan. B) Immunogenicity will be evaluated by assessing induction and frequency of p53-specific T cells by proliferation and IFN-γ ELISPOT.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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In case of vaccine related serieus Adverse Events, these will be investigated and judgement will be made whether continuation of trial is considered safe. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |