A phase II trial to assess the activity of Trovax versus placebo in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer who have relapsed but who do not have any symptoms.
- Conditions
- Patients with relapsed asymptomatic epithelial ovarian, fallopian tube or primary peritoneal cancerMedDRA version: 19.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2011-001836-44-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 96
•Aged =18 years with histologically or cytologically proven advanced epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma.
• Stage IC1 – III or Stage IVA* (pleural effusion only) at diagnosis.
*According to new FIGO staging effective 01/01/2014
•Completed cytoreductive surgery during the phase of first-line therapy including removal of bulky tumour masses and adequate surgical staging including a minimum of bilateral salpingo-ophorectomy, hysterectomy and omentectomy.
•Completed first line platinum-based chemotherapy
OR
Completed first line platinum-based chemotherapy and second line chemotherapy of any type with complete response to second line treatment according to RECIST 1.1
•Have developed relapse =6 months after platinum-based chemotherapy (in the case of second relapse, the disease free interval should also be =6 months)
•Normal CA-125 following platinum-based chemotherapy
•Have developed asymptomatic relapse as defined by:
1.CA125 = 2xULN
OR
2. Low volume radiological disease* and CA125>ULN
*Low volume radiological disease is defined as radiologically visible disease excluding intra-hepatic (parenchymal) liver or splenic metastases, ascites or pleural effusion thought to require drainage within the next 2 months.
The following are acceptable: Subcapsular liver and splenic lesions, benign lesions or cysts, any suspicious lesions that may represent metastases have to be confirmed by further imaging to be non-metastatic.
•Currently asymptomatic and does not require chemotherapy.
•Subject is assumed to be clinically immunocompetent and is free of clinically apparent/active autoimmune disease (i.e. no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave’s disease, Hashimoto’s thyroiditis, multiple sclerosis, and rheumatoid arthritis). Note: subjects with type I or type II diabetes mellitus can be included, as can subjects with controlled and rarely flaring rheumatoid disease (defined as recent flare within 6 months prior to registration)
•Subject has adequate bone marrow function as defined by Haemoglobin = 110 g/L, white cell count = 3.0 x 109/L, Absolute Lymphocyte Count (ALC) = 1.0 x 109/L, Absolute Neutrophil Count (ANC) =1.5 x 109/L , Platelet Count = 100 x 109/L and <400 x 109/L, Monocytes <0.8 x 109/L (for patients who have undergone previous splenectomy monocyte count can be < 1.2 x 109/L)
•Adequate end-organ function: creatinine = 2x upper limit of normal, AST and/or ALT = 2x upper limit of normal, Total Bilirubin = 1.5x upper limit normal
•ECOG performance status 0-1
•Life expectancy =6 months and willing to be available to attend clinic visits for treatment and for follow-up
•Ability to give written informed consent
•To be treated no later than 14 days from registration
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34
•Carcino-sarcoma/MMMT
•Cancer related symptoms, or disease recurrence requiring immediate treatment
•CT scan showing bulky disease requiring chemotherapy, as judged by the investigator
•Patients with low volume radiological disease in any of the following sites at trial entry:
- Accumulating ascites thought to require drainage within the next 2 months
- Pleural effusion thought to require drainage within the next 2 months
- Intraparenchymal Liver and/or splenic metastases
•Major surgery, radiotherapy, immunotherapy, hormone therapy or chemotherapy completed < 4 weeks prior to registration
•Patients who are deemed as being immunosuppressed, receiving > 4 weeks parenteral or oral steroids, (nasal sprays and inhalers are permitted), or receiving immunosuppressive therapy following transplant
•Chronic (= 6 months) oral corticosteroid use except when prescribed as replacement therapy in the case of adrenal insufficiency. If previously used for =6 months then must have discontinued =3 months prior to registration
•Currently active” second malignancy, other than non-melanoma skin cancer. Subjects are not considered to have a currently active” malignancy if they have completed chemotherapy, surgery, radiotherapy =3 years previously and have no known evidence of residual or recurrent disease
•Concomitant use of complementary medicines/botanicals. Supplements and conventional multivitamins are acceptable.
•Evidence of significant clinical disorder or laboratory finding which in the opinion of the investigator makes it undesirable for the patient to participate in the trial. No participant should have a serious or uncontrolled intercurrent infection (including those positive for HIV, hepatitis B or C)
•Psychiatric illnesses/social situations that limit compliance with protocol requirements
•Allergy to egg proteins or history of allergic response to vaccinia vaccines
•Prior exposure to TroVax®
•Cerebral metastases (known from previous investigations or clinically detectable, surgically resected)
•Patients on active treatment as part of another clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method