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Carcinoma, Small Cell LungPhase 3NCT00037713

Survival in a Randomized Phase III Trial in Patients With Limited Disease (LD) Small Cell Lung Cancer Vaccinated With Adjuvant BEC2 and BCG

A Phase 3 study testing BEC2 Vaccine in people with Carcinoma, Small Cell Lung, run by Eli Lilly and Company.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is designed to test the impact of adjuvant BEC2 (2.5 mg)/BCG vaccination on survival in patients with LD Small Cell Lung Cancer (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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Small Cell Lung
What is being tested?
BEC2 Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
515 participants
Where
No sites listed yet
Study dates
Sep 1998to Oct 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histo-cytologically proven SCLC
  • Limited disease at diagnosis
  • Age greater than or equal to 18
  • Patients with a clinical response of CR or PR to first line combined modality therapy
  • KPS greater than or equal to 60
  • Adequate bone marrow, liver and heart functions
  • Written informed Consent

Who cannot join

  • Prior surgical treatment for SCLC
  • History of tuberculosis
  • NCIC CTG grade 3 local skin toxicity reaction (ulceration) to > IU PPD test > 5 IU
  • HIV positive
  • Splenectomy or spleen radiation therapy in medical history
  • Prior therapy to proteins of murine origin
Show all 15Show fewer
  • Any second line therapy for SCLC
  • Investigational agent or immune therapy within 4 weeks prior to study randomization
  • Severe active infections
  • Active infections requiring systemic antibiotics, antiviral, or antifungal treatments
  • Serious unstable chronic illness
  • The use of systemic anti-histamines, NSAID or systemic corticosteroids
  • 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
  • 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.

About this study

Official title: The SILVA Study: Survival in an International Phase III Prospective Randomized LD Small Cell Lung Cancer Vaccination Study With Adjuvant BEC2 and BCG

This trial is designed to test the impact of adjuvant BEC2 (2.5 mg)/BCG vaccination on survival in patients with LD Small Cell Lung Cancer (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.

Being tested
BEC2 Vaccine
Keywords
LD Small Cell Lung Cancer, BEC2, vaccine, adjuvant, monoclonal antibody, LD Small Cell Lung Cancer (VA Classification, Zelen, 1973)
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEC2 VaccineBiological

    5 vaccinations of BEC2 (2.5 mg) + BCG given day 1 of weeks 0,2,4,6 \& 10.

Study groups in NCT00037713
Study groupRoleWhat they receive
1No interventionBest supportive care, but no cancer specific therapy (cytotoxic, radiation or other tumor reductive therapy) can be given until documented progression of disease.
2ExperimentalTreatment will consist of 5 vaccinations (each consisting of 8 single intradermal injections) over a period of 10 to 12 weeks unless one of the following occur: 1. intolerable toxicity precluding further treatment progression of disease 2. patient refusal 3. occurrence of pregnancy
Receives: Biological: BEC2 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: 6 monthly basis until progression of disease

Secondary outcomes (4)

  1. Progression-free survival

    Measured: 6 monthly basis until progression of disease

  2. Safety

    Measured: 6 monthly basis until progression of disease

  3. Quality of Life

    Measured: 6 monthly basis until progression of disease

  4. Health Economics Aspects

    Measured: 6 monthly basis until progression of disease

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2002 (estimated)
  2. Study startSep 1998
  3. Primary completionOct 2002
  4. Study completionOct 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00037713
Sponsor's protocol ID
SILVA EORTC 08971
Status last verified
Apr 2010
First submitted
20 May 2002
Last updated
8 Apr 2010
Results posted
No
Data monitoring committee
No

Publications

  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

    PubMed 8433390

  • Sprangers MA, Cull A, Bjordal K, Groenvold M, Aaronson NK. The European Organization for Research and Treatment of Cancer. Approach to quality of life assessment: guidelines for developing questionnaire modules. EORTC Study Group on Quality of Life. Qual Life Res. 1993 Aug;2(4):287-95. doi: 10.1007/BF00434800.

    PubMed 8220363

  • Stiggelbout AM, Eijkemans MJ, Kiebert GM, Kievit J, Leer JW, De Haes HJ. The 'utility' of the visual analog scale in medical decision making and technology assessment. Is it an alternative to the time trade-off? Int J Technol Assess Health Care. 1996 Spring;12(2):291-8. doi: 10.1017/s0266462300009648.

    PubMed 8707502

  • Chapman PB, Houghton AN. Induction of IgG antibodies against GD3 ganglioside in rabbits by an anti-idiotypic monoclonal antibody. J Clin Invest. 1991 Jul;88(1):186-92. doi: 10.1172/JCI115276.

    PubMed 2056117

  • Dunn PL, Johnson CA, Styles JM, Pease SS, Dean CJ. Vaccination with syngeneic monoclonal anti-idiotype protects against a tumour challenge. Immunology. 1987 Feb;60(2):181-6.

    PubMed 3817870

  • Ertl HC, Finberg RW. Sendai virus-specific T-cell clones: induction of cytolytic T cells by an anti-idiotypic antibody directed against a helper T-cell clone. Proc Natl Acad Sci U S A. 1984 May;81(9):2850-4. doi: 10.1073/pnas.81.9.2850.

    PubMed 6326148

  • Fuentes R, Allman R, Mason MD. Ganglioside expression in lung cancer cell lines. Lung Cancer. 1997 Aug;18(1):21-33. doi: 10.1016/s0169-5002(97)00049-4.

    PubMed 9268945

  • Gaulton GN, Sharpe AH, Chang DW, Fields BN, Greene MI. Syngeneic monoclonal internal image anti-idiotopes as prophylactic vaccines. J Immunol. 1986 Nov 1;137(9):2930-6.

    PubMed 3020129

  • Giaccone G, Dalesio O, McVie GJ, Kirkpatrick A, Postmus PE, Burghouts JT, Bakker W, Koolen MG, Vendrik CP, Roozendaal KJ, et al. Maintenance chemotherapy in small-cell lung cancer: long-term results of a randomized trial. European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group. J Clin Oncol. 1993 Jul;11(7):1230-40. doi: 10.1200/JCO.1993.11.7.1230.

    PubMed 8391065

  • Grant SC, Kris MG, Houghton AN, Chapman PB. Long survival of patients with small cell lung cancer after adjuvant treatment with the anti-idiotypic antibody BEC2 plus Bacillus Calmette-Guerin. Clin Cancer Res. 1999 Jun;5(6):1319-23.

    PubMed 10389914

  • Iwamori M, Nagai Y. A new chromatographic approach to the resolution of individual gangliosides. Ganglioside mapping. Biochim Biophys Acta. 1978 Feb 27;528(2):257-67.

    PubMed 623779

  • Iwamori M, Nagai Y. Ganglioside composition of rabbit thymus. Biochim Biophys Acta. 1981 Aug 24;665(2):205-13. doi: 10.1016/0005-2760(81)90004-7.

    PubMed 7284420

  • Iwamori M, Nagai Y. Isolation and characterization of GD3 ganglioside having a novel disialosyl residue from rabbit thymus. J Biol Chem. 1978 Nov 25;253(22):8328-31.

    PubMed 711756

  • Iwamori M, Nagai Y. Comparative study on ganglioside compositions of various rabbit tissues. Tissue-specificity in ganglioside molecular species of rabbit thymus. Biochim Biophys Acta. 1981 Aug 24;665(2):214-20. doi: 10.1016/0005-2760(81)90005-9.

    PubMed 7284421

  • Kahn M, Hellstrom I, Estin CD, Hellstrom KE. Monoclonal antiidiotypic antibodies related to the p97 human melanoma antigen. Cancer Res. 1989 Jun 15;49(12):3157-62.

    PubMed 2470502

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BEC2 Vaccine in people with Carcinoma, Small Cell Lung, run by Eli Lilly and Company.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 6 monthly basis until progression of disease). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00037713, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2010.

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