p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer

NCT ID: NCT00844506

Last Updated: 2011-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-07-31

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

P53-SLP vaccine

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).

Intervention Type: DRUG

Cyclophosphamide

Two days prior to each peptide vaccination, patients will receive 300mg/m2 cyclophosphamide i.v.

Intervention Type: DRUG

Other Intervention Names

Endoxan; Cytoxan

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ISA Pharmaceuticals B.V.

INDUSTRY

Sponsor Role: collaborator

Dutch Cancer Society

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

University Medical Centre Groningen

Principal Investigators

H. W. Nijman, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Centre Groningen

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 19188184 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17415711 (View on PubMed)

Other Identifiers

EUDRACT 2007-007734-19

Identifier Type: -

Identifier Source: secondary_id

CCMO NL21308.000.07

Identifier Type: -

Identifier Source: secondary_id

ISA-P53-CTX

Identifier Type: -

Identifier Source: org_study_id