Download BMS SCLC CA184156 - Highlands Cancer Center

BMS SCLC CA184156:
Inclusion/Exclusion Criteria
Inclusion Criteria
1. Signed Written Informed Consent (willing and able to provide informed consent).
2. Subjects with SCLC documented by histology or cytology from brushing, washing, or
needle aspiration of a defined lesion but not from sputum cytology alone.
3. Subjects must present extensive stage disease (VALG classification).
4. Eastern Cooperative Oncology Group (ECOG) performance status < 1.
5. Accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at
the participating centers.
6. Men and Women > 18 years of age.
7. Women of child bearing potential (WOCBP) and men must be using an acceptable
method of contraception to avoid pregnancy throughout the study and for up to 12 weeks
after the last dose of study drug in such manner that the risk of pregnancy is minimized.
See section 3.3.3 for the definition of WOCBP.
8. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25
IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational
product.
9. Women must not be breastfeeding.
10. Sexually active fertile men must use effective birth control if their partners are WOCBP.
Exclusion Criteria
1. CNS metastases unless non-symptomatic (ie, no neurological deficit, epilepsy or other
signs and symptoms typical of CNS metastases), and not requiring treatment with
steroids or anticonvulsant medications. In addition, if treated with radiation therapy, CNS
mets must be stable with no evidence of progression on scans for at least 30 days from
the initial radiologic diagnosis of CNS mets.
2. Malignant pleural effusion that is recurrent despite appropriate supportive care.
3. Documented history of severe autoimmune or immune mediated symptomatic disease
that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids)
treatments such as: Ulcerative colitis and Crohn’s disease, Rheumatoid arthritis, systemic
progressive sclerosis (scleroderma), Systemic Lupus Erythematous, Autoimmune
vaculitis (ie, Wegener’s Granulomatosis).
4. Subjects with a history of toxic epidermal necrolysis (TEN).
5. Interstitial pneumonia or pulmonary fibrosis.
6. Paraneoplastioc autoimmune syndrome.
7. Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent or completing questionnaires.
8. Serious uncontrolled medical disorder that, in the opinion of the investigator, would impair
the ability of the subject to receive protocol therapy.
9. Prior malignancy, active within 5 years, except for locally curable cancers that have been
apparently cured and need no subsequent therapy, such as basal or squamous cell skin
cancer, superficial bladder cancer of carcinoma in situ of the cervix or breast.
10. HIV, active Hepatitis B, or active Hepatitis C infection, based on testing performed during
the CA184156 screening period. In the event of a positive HIV or anti-HCV antibody test,
results of confirmatory testing must be awaited before randomization.
11. Prior systemic therapy of loco-regional surgeries are allowed if performed at least 3
weeks prior to the start of study therapy.
12. Subjects with > Grade 2 peripheral neuropathy.
13. Inadequate hematologic function defined by:
14. Absolute neutrophil count (ANC), 1,500 mm3.
15. Platelet count, 100,000/ mm3.
16. Hempoglobin level, 9 g/dL.
17. Inadequate hepatic function:
18. Total bilirubin level > 2.5 times the ULN.
19. AST and ALT levels > 2.5 times the ULN.
20. Inadequate renal function defined as calculated creatinine clearance < 50 ml/min based
on the standard Cockroft and Gault formula.
21. Sodium (Na) < 130 mmol/l.
22. Chronic use of immune-suppressive drugs (ie. Corticosteroids used in the management
of cancer or non-cancer related illnesses). Use of corticosteroids are allowed if used as
premedication for chemotherapy administration or on-study management of an AE.
23. Any non-oncology vaccine therapy used for prevention of infectious disease (for up to 4
weeks prior to or after any dose of blinded study drug).
24. Any immunotherapy for the treatment of cancer.
25. Prior treatment with any inhibitor or agonist of T-cell co-stimulation.
26. Prisoners or subjects who are involuntary incarcerated.
27. Subjects who are compulsorily detained for treatment of either a psychiatrist or physical
(eg, infectious disease) illness.
*Eligibility criteria for this study have been carefully considered to ensure the safety of the
study subjects and to ensure that the results of the study can be used. It is imperative that
subjects fully meet all eligibility criteria.