A Phase II trial of the addition of Ipilimumab to Carboplatin and Etoposide chemotherapy for the treatment of Extensive Stage Small Cell Lung Cancer
- Conditions
- Extensive stage small cell lung cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-021863-34-GB
- Lead Sponsor
- niversity Hospital Southampton NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
• Willing and able to give written informed consent. • Histologic or cytological diagnosis of small cell lung cancer. • No active or chronic infection with HIV, Hepatitis B, or Hepatitis C. • Performance status ECOG 0 or 1, • Men and women, of or over 18 years of age.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
• Limited stage small cell lung cancer, appropriate for radical treatment with chemoradiation • Symptomatic CNS metastases (patients with asymptomatic CNS metastases – treated or untreated – may be included in the trial) • Any other malignancy from which the patient has been disease-free for less than 5 years, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix. • Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis, Lambert Eaton Myasthenic syndrome). • Any underlying medical, neurological or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea. • Any live vaccine used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab). • Previous chemotherapy for small cell lung cancer, except for patients who have received up to two cycles of Carboplatin and Etoposide at comparible doses to those recommended in the protocol. These patients will be allowed to join the trial at cycle 2 or 3. • A history of prior treatment with ipilimumab, prior CD137 agonist or CTLA 4 inhibitor or agonist. • Concomitant therapy with any of the following: Interleukin 2, interferon, or other non-study immunotherapy regimens; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids. • Women of childbearing potential (WOCBP), as defined as below and who: • Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the duration of their participation in the study and for at least 8 weeks after cessation of study drug, or • Have a positive pregnancy test at baseline, or • Are pregnant or breastfeeding. • Sexually active WOCBP must use an effective method of birth control during the course of the study and for up to 26 weeks after last dose of ipilimumab, in a manner such that risk of failure is minimized. Before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy. All WOCBP must have a negative pregnancy test before first receiving ipilimumab. If the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal. Post-menopause is defined as: Amenorrhea ? 12 consecutive months without another cause, or for women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level ? 35 mIU/mL. Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products s
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