ISA-P53-CTX: p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer

• Sponsor: University Medical Center Groningen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00844506
• Collaborator: ISA Pharmaceuticals B.V. (Industry), Dutch Cancer Society (Other)
• Enrollment: 19
• Location: 1
• Duration (Months): 9
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: P53-SLP vaccine; Drug: Cyclophosphamide	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer a Phase II Trial
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Outcome Measures

Primary Outcome Measures

1. 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]

2. Immunogenicity will be evaluated by assessing induction and frequency of p53-specific T cells by proliferation and IFN-γ ELISPOT. [after fourth immunization]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Centre Groningen	Groningen		Netherlands	9700 RB

Sponsors and Collaborators

• University Medical Center Groningen
• ISA Pharmaceuticals B.V.
• Dutch Cancer Society

Investigators

• Principal Investigator: H. W. Nijman, MD, University Medical Center Groningen

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00844506
• Other Study ID Numbers: ISA-P53-CTX; EUDRACT 2007-007734-19; CCMO NL21308.000.07
• First Posted: Feb 16, 2009
• Last Update Posted: Feb 25, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Ovarian cancer patients with recurrent disease
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Cyclophosphamide

Study Results

No Results Posted as of Feb 25, 2011