p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer
Information source: University Medical Centre Groningen
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Cancer
Intervention: P53-SLP vaccine (Drug); Cyclophosphamide (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Medical Centre Groningen Official(s) and/or principal investigator(s):
H. W. Nijman, MD, Principal Investigator, Affiliation: University Medical Centre Groningen
Overall contact:
H. W. Nijman, MD PhD, Phone: +31 50 3616161, Email: h.w.nijman@og.umcg.nl
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.
Clinical Details
Official title: p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer a Phase II Trial
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: 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.Immunogenicity will be evaluated by assessing induction and frequency of p53-specific T cells by proliferation and IFN-γ ELISPOT.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
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.
- 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).
Locations and Contacts
H. W. Nijman, MD PhD, Phone: +31 50 3616161, Email: h.w.nijman@og.umcg.nl
University Medical Centre Groningen, Groningen 9700 RB, Netherlands; Recruiting
Additional Information
Related publications: 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. 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.
Starting date: October 2008
Last updated: February 13, 2009
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