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

This study has been completed.
Sponsor:
Collaborators:
ISA Pharmaceutical B.V.
Dutch Cancer Society
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00844506
First received: February 13, 2009
Last updated: February 24, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Ovarian Cancer
 Drug: P53-SLP vaccine
Drug: Cyclophosphamide
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer a Phase II Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • 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. [ Time Frame: day 105 - 126 after first gift of cyclophosphamide ] [ Designated as safety issue: No ]
  • Immunogenicity will be evaluated by assessing induction and frequency of p53-specific T cells by proliferation and IFN-γ ELISPOT. [ Time Frame: after fourth immunization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: durante study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 19
Study Start Date: October 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 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).
    Drug: Cyclophosphamide
    Two days prior to each peptide vaccination, patients will receive 300mg/m2 cyclophosphamide i.v.
    Other Names:
    • Endoxan
    • Cytoxan
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844506

Locations
Netherlands
University Medical Centre Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Centre Groningen
ISA Pharmaceutical B.V.
Dutch Cancer Society
Investigators
Principal Investigator: H. W. Nijman, MD University Medical Centre Groningen
  More Information

Publications:

Responsible Party: Prof. Dr. H.W. Nijman, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT00844506     History of Changes
Other Study ID Numbers: ISA-P53-CTX, EUDRACT 2007-007734-19, CCMO NL21308.000.07
Study First Received: February 13, 2009
Last Updated: February 24, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by University Medical Centre Groningen:
Ovarian cancer patients with recurrent disease

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cyclophosphamide
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 19, 2013