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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
P53-SLP vaccine
Cyclophosphamide
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian cancer patients with recurrent disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • University Medical Centre Groningen

Outcomes

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.
Immunogenicity will be evaluated by assessing induction and frequency of p53-specific T cells by proliferation and IFN-γ ELISPOT.

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.

Full Information

First Posted
February 13, 2009
Last Updated
February 24, 2011
Sponsor
University Medical Center Groningen
Collaborators
ISA Pharmaceuticals B.V., Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT00844506
Brief Title
p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer
Acronym
ISA-P53-CTX
Official Title
p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer a Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Medical Center Groningen
Collaborators
ISA Pharmaceuticals B.V., Dutch Cancer Society

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian cancer patients with recurrent disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
P53-SLP vaccine
Intervention Description
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
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Endoxan, Cytoxan
Intervention Description
Two days prior to each peptide vaccination, patients will receive 300mg/m2 cyclophosphamide i.v.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. W. Nijman, MD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19188184
Citation
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.
Results Reference
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PubMed Identifier
17415711
Citation
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.
Results Reference
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p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer

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