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Home > "S" Clinical Trials Conditions > Survival in a Randomized Phase III Trial in Patients with LD Small Cell Lung Cancer Vaccinated with Adjuvant BEC2 and BCG  Survival in a Randomized Phase III Trial in Patients with LD Small Cell Lung Cancer Vaccinated with Adjuvant BEC2 and BCG
Survival in a Randomized Phase III Trial in Patients with LD Small Cell Lung Cancer Vaccinated with Adjuvant BEC2 and BCG
For Condition: Carcinoma, Small Cell Lung
Status: No longer recruiting
Sponsor(s): European Organization for Research and Treatment of Cancer , ImClone Systems,Merck KGaA
Synopsis: This trial is designed to test the impact of adjuvant BEC2 (2.5 mg)/BCG vaccination on survival in patients with LD SCLC. Patients will be stratified by institution, KPS (60 - 70% vs 80 - 100%), and response to first line combined modality therapy (CR vs PR) that consisted of at least a 2 drug regimen (4 - 6 cycles) and a chest radiotherapy regimen. Patients will be randomized to one of two treatment arms: standard arm (Observational cohort) or best supportive care, or the treatment arm (5 intradermal vaccinations of BEC2 (2.5 mg) + BCG given on day 1 of weeks 0, 2, 4, 6, and 10.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Placebo Control, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - 1)Histo-cytologically proven SCLC - 2)Limited disease at diagnosis - 3)Age greater than or equal to 18 - 4)Patients with a clinical response of CR or PR to first line combined modality therapy - 5)KPS greater than or equal to 60 - 6)Adequate bone marrow, liver and heart functions - 7)Written informed Consent Exclusion Criteria: - 1)Prior surgical treatment for SCLC - 2)History of tuberculosis - 3)NCIC CTG grade 3 local skin toxicity reaction (ulceration) to > IU PPD test > 5 IU - 4)HIV positive - 5)Splenectomy or spleen radiation therapy in medical history - 6)Prior therapy to proteins of murine origin - 7)Any second line therapy for SCLC Investigational agent or immune therapy within 4 weeks prior to study randomization - 8)Severe active infections - 9)Active infections requiring systemic antibiotics, antiviral, or antifungal treatments - 10)Serious unstable chronic illness - 11)The use of systemic anti-histamines, NSAID or systemic corticosteroids - 12)Any previous malignancy except adequately treated CIS of the cervix or non melanoma skin cancer or if previous malignancy was more than 5 years prior and there are no signs of recurrence - 13)Pregnancy or breast feeding or absence of adequate contraception for fertile patients - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before randomization in the trial.
Total Enrollment: 500
Location and Contact Information:
Additional Information:
Study ID Numbers: SILVA EORTC 08971;
Study Start Date: September 1998
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037713
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Survival in a Randomized Phase III Trial in Patients with LD Small Cell Lung Cancer Vaccinated with Adjuvant BEC2 and BCG
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