A Phase II trial of cellular immunotherapy on CA-125 response with M-FP cancer vaccine in patients with epithelial ovarian carcinoma

Phase 2

Completed

• Conditions: Ovarian Cancer; Cancer - Ovarian and primary peritoneal

• Registration Number: ACTRN12605000442606
• Lead Sponsor: Cancer Vac Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Histologically or cytologically proven epithelial adenocarcinoma of ovarian or fallopian tube origin, or primary peritoneal carcinoma. - No options for curative therapy. - Rising CA-125, which is defined as an increase in CA-125 by at least 25% from a baseline reading within one month. A repeat CA-125 test must be done to confirm the increased value. At least one level must be greater than or equal to twice the upper limit of the normal range (ULNR). - No surgery, radiotherapy, chemotherapy, hormonal therapy for malignancy, immunotherapy or experimental therapy within the last 4 weeks. - Adequate bone marrow function (white blood cells >3.0 x 109 per litre, haemoglobin > 100 g/L, platelets >100 x 109 per litre). - Adequate liver function (bilirubin < 2 x ULNR, AST or ALT < 5 x ULNR). - Adequate renal function (creatinine within normal ranges). - At least 18 years of age. - Life expectancy of at least 6 months. - ECOG Performance Status of 0 - 1 inclusive (Ambulatory and able to carry out activities of daily living). - Written informed consent given by the patient.

Exclusion Criteria

Coexisting or previous other malignancies unless in complete remission for not less than 2 years and excepting in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin. - Ovarian sarcoma / mixed Mullerian tumours. - Active uncontrolled infections. - Psychiatric, addictive or any (medical) disorder which compromises ability to give truly informed consent for participation in this study or comply with the requirements of the study. - Any serious medical condition that may prevent the participant from completing at least the first six months of the study. - Concurrent systemic steroid treatment. - Clinical autoimmune disease, eg rheumatoid arthritis, systemic lupus erythematosus, (except autoimmune thyroiditis). - Clinically significant ischaemic heart disease (unstable angina or acute myocardial infarction within the last 3 months) or cardiac failure (NYHA Class III or IV) - see Appendix A. - Infection with the Human Immunodeficiency (AIDS) Virus, hepatitis B virus or hepatitis C virus. - Pregnant or breast feeding, or planning to become pregnant during the course of the study. - Evidence of CNS metastases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether cellular immunotherapy with M-FP cancer vaccine can lead to clinical responses or stabilisation of disease, as determined by serum CA-125, in patients with adenocarcinoma of the ovary. [Measured from visit 5 onwards for each patient.]