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p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer a Phase II Trial


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

p53 Synthetic Long Peptides Vaccine With Cyclophosphamide for Ovarian Cancer a Phase II Trial


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
╬╝mol/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).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

day 105 - 126 after first gift of cyclophosphamide

Safety Issue:

No

Principal Investigator

H. W. Nijman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Groningen

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

ISA-P53-CTX

NCT ID:

NCT00844506

Start Date:

October 2008

Completion Date:

July 2009

Related Keywords:

  • Ovarian Cancer
  • Ovarian cancer patients with recurrent disease
  • Ovarian Neoplasms

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