p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer
ISA-P53-CTX
3 other identifiers
interventional
19
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 ovarian-cancer
Started Oct 2008
Shorter than P25 for phase_2 ovarian-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 13, 2009
CompletedFirst Posted
Study publicly available on registry
February 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedFebruary 25, 2011
February 1, 2011
9 months
February 13, 2009
February 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
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
Interventions
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).
Two days prior to each peptide vaccination, patients will receive 300mg/m2 cyclophosphamide i.v.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Medical Center Groningenlead
- ISA Pharmaceuticals B.V.collaborator
- Dutch Cancer Societycollaborator
Study Sites (1)
University Medical Centre Groningen
Groningen, Provincie Groningen, 9700 RB, Netherlands
Related Publications (2)
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.
PMID: 19188184BACKGROUNDLambeck 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.
PMID: 17415711BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
H. W. Nijman, MD
University Medical Center Groningen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 13, 2009
First Posted
February 16, 2009
Study Start
October 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
February 25, 2011
Record last verified: 2011-02