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Immunotherapy With Racotumomab in Advanced Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01460472
Recruitment Status : Unknown
Verified July 2016 by Recombio SL.
Recruitment status was:  Active, not recruiting
First Posted : October 26, 2011
Last Update Posted : July 29, 2016
Sponsor:
Collaborators:
CIMAB (Cuba)
Laboratorio Elea Phoenix S.A.
Innogene Kalbiotech Pte. Ltd
Eurofarma Laboratorios S.A.
Information provided by (Responsible Party):
Recombio SL

Study Description
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Brief Summary:
This is a prospective, randomized, open label, parallel-group, multicenter phase III study to evaluate the efficacy and safety of active specific immunotherapy with racotumomab plus best supportive care versus best supportive care in patients with advanced NSCLC who have achieved an Objective Response (Partial or Complete Response) or Stable Disease with standard first-line treatment. Also immunological parameters will be evaluated. Best supportive therapy will be administered to all patients in the study according to institutional standards and includes any subsequent onco-specific therapies. 1082 patients will be included in the study, with non-small cell lung cancer in stages IIIA (non-resectable), IIIB or IV.

Condition or disease Intervention/treatment Phase
NSCLC Lung Cancer, Non-small Cell Biological: Racotumomab Other: Best Support Treatment Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1082 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multicenter, Open Label Phase III Study of Active Specific Immunotherapy With Racotumomab Plus Best Support Treatment Versus Best Support Treatment in Patients With Advanced Non-small Cell Lung Camcer.
Study Start Date : September 2010
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Racotumomab plus Best Support Treatment
Patients will receive Racotumomab and Best Support Treatment, which includes any further onco-specific therapy for progressive disease.
 Biological: Racotumomab
Patients will receive best support treatment and vaccination with racotumomab. The vaccination schedule is as follows: 5 doses (1mg/mL each), intradermally, every 2 weeks (induction period) followed by monthly vaccinations until any criteria for discontinuation are met. If disease progression occurs and further onco-specific therapy is indicated, the patient will be able to continue in the study and vaccination will not be interrupted unless criteria for vaccine discontinuation are met.
Other Name: 1E10
Active Comparator: Best Support Treatment
Patients will receive best support treatment for advanced NSCLC including onco-specific therapies when disease progresses.
 Other: Best Support Treatment
Patients will receive best support treatment for advanced NSCLC as per each institution's standards, including onco-specific therapies when disease progresses.


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Until date of death or last censored observation, on average upto 17 months ]
    A comparison of survival in the subgroup of inoperable stage IIIA and dry IIIB will be performed in 757 (approximately 70% of the study population)


Secondary Outcome Measures :
  1. Number of Participants with Adverse events as a measure of safety and tolerability [ Time Frame: Until death, on average during 17 months ]
    Safety will be evaluated at each study visit according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 and will include physical examination with vital signs, performance status as per the Eastern Cooperative Oncology Group scale(ECOG scale), laboratory tests and clinical history.

  2. Progression Free Survival [ Time Frame: From randomization until date of first documented progression of disease, assessed as per RECIST 1.0 during an expected average of 17 months ]
    Tumour evaluations will be performed every 2 months and evaluated as per Response Evaluation Criteria in Solid Tumors (RECIST).

  3. Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside [ Time Frame: Baseline ]
  4. Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group [ Time Frame: Month 3 ]
  5. Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group [ Time Frame: Month 6 ]
  6. Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group [ Time Frame: Month 9 ]
  7. Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group [ Time Frame: Month 12 ]
  8. Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Racotumomab Group [ Time Frame: After the first year, every 3 months, on average for 17 months ]
  9. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay. [ Time Frame: Baseline ]
  10. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group. [ Time Frame: Month 3 ]
  11. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group. [ Time Frame: Month 6 ]
  12. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group. [ Time Frame: Month 9 ]
  13. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Racotumomab Group. [ Time Frame: Month 12 ]
  14. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group [ Time Frame: Baseline ]
  15. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse yeloma) for Racotumomab Group [ Time Frame: Month 3 ]
  16. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group [ Time Frame: Month 6 ]
  17. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group [ Time Frame: Month 9 ]
  18. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Racotumomab Group [ Time Frame: Month 12 ]
  19. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Best Support Treatment Group [ Time Frame: Baseline ]
  20. Evaluation of the reactivity if the antibodies against X63 tumor line (mouse myeloma) for Best Support Treatment Group [ Time Frame: Month 4 ]
  21. Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Best Support Treatment Group [ Time Frame: Baseline ]
  22. Determination of IgM and IgG antibody titers against N-Glycolil-GM3 ganglioside for Best Support Treatment Group [ Time Frame: Month 4 ]
  23. Determination of gamma interferon by ELISPOT (enzyme-linked immunosorbent spot) assay for Best Support Treatment Group. [ Time Frame: Month 4 ]
  24. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry. [ Time Frame: Baseline ]
  25. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group. [ Time Frame: Month 3 ]
  26. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group. [ Time Frame: Month 6 ]
  27. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group. [ Time Frame: Month 9 ]
  28. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Racotumomab Group. [ Time Frame: Month 12 ]
  29. Determination of T supressor cell (Treg cell) frequency by immunostaining and flow cytometry in the Best Support Treatment Group. [ Time Frame: Month 4 ]
  30. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) [ Time Frame: Baseline ]
  31. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group. [ Time Frame: Month 3 ]
  32. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group. [ Time Frame: Month 6 ]
  33. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group. [ Time Frame: Month 9 ]
  34. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Racotumomab Group. [ Time Frame: Month 12 ]
  35. Evaluation of the reactivity of the antibodies against the patients tumoral tissue (whenever samples are available) in the Best Support Treatment Group. [ Time Frame: Month 4 ]
  36. Measurement of pro-inflammatory and anti-inflammatory cytokines [ Time Frame: Baseline ]
  37. Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group [ Time Frame: Month 3 ]
  38. Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group [ Time Frame: Month 6 ]
  39. Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group [ Time Frame: Month 9 ]
  40. Measurement of pro-inflammatory and anti-inflammatory cytokines in the Racotumomab Group [ Time Frame: Month 12 ]
  41. Measurement of pro-inflammatory and anti-inflammatory cytokines in the Best Support Treatment Group [ Time Frame: Month 4 ]
  42. Determination of anti-idiotypic IgG response [ Time Frame: Baseline ]
  43. Determination of anti-idiotypic IgG response in the Racotumomab Group. [ Time Frame: Month 3 ]
  44. Determination of anti-idiotypic IgG response in the Racotumomab Group. [ Time Frame: Month 6 ]
  45. Determination of anti-idiotypic IgG response in the Racotumomab Group. [ Time Frame: Month 9 ]
  46. Determination of anti-idiotypic IgG response in the Racotumomab Group. [ Time Frame: Month 12 ]
  47. Determination of anti-idiotypic IgG response in the Best Support Treatment Group. [ Time Frame: Month 4 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntarily signed informed consent.
  2. Cytologic or histologically diagnosed NSCLC in stages IIIA (non-resectable) or IIIB or IV (TNM).
  3. In continuous complete or partial remission or stable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) after standard first-line treatment.
  4. Imaging studies documenting the response to first-line therapy must be available for evaluation by the investigator.
  5. Time lapse of 21 to 56 days between the end of onco-specific treatment and start of vaccination. Patients must have recovered from any acute toxicity produced by previous therapy.
  6. Age greater than or equal to 18 years, either sex.
  7. Eastern Cooperative Oncology Group performance status less than 2.

  8. Adequate organ function, defined as follows:

    8.1. Electrocardiogram (ECG) without significant anomalies, performed in the 7 days preceding entry

    8.2. Haemoglobin greater than or equal to 90 g/L

    8.3. Total white blood cell count (WBC) greater than or equal to 3.0 x 10^9/L

    8.4. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L

    8.5. Platelet count greater than 100 x 10^9/L

    8.6. Total bilirubin less than or equal to 1.5 fold the maximum normal value at the place of evaluation or 2.5 fold the maximum normal value in case of liver metastases

    8.7. Glutamic-oxaloacetic transaminase/aspartate aminotransferase (GOT/AST), and glutamic-pyruvic transaminase/alanine aminotransferase (GPT/ALT), less than or equal to 2.5 fold the maximum normal value at the place of evaluation (in case of liver metastasis, less than 5 fold the maximum normal value)

    8.8. Creatinine less than or equal to 2 mg/dL (less than or equal to 176 µmol/L)

  9. Known hepatitis B virus carriers who have liver function tests within the accepted limits are eligible

Exclusion Criteria:

  1. Pregnant or breastfeeding patients
  2. Known hypersensitivity to any component of the formulation
  3. Fertile patients of either sex who do not use adequate contraceptive methods while on treatment
  4. Disease progression prior to randomization
  5. Recurrent NSCLC, who relapse less than one year after completing curative intent therapy
  6. Patients receiving other investigational medication (including investigational immunotherapy for NSCLC) or having received such medication within 30 days before entering the protocol
  7. Autoimmune diseases or chronic decompensated diseases
  8. Acute allergic disorders or a history of severe allergic reactions
  9. Known brain metastases
  10. History of demyelinating disease or inflammatory disease of the central nervous system or the peripheral nervous system
  11. Non-controlled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable chest angina or heart arrhythmia, as well as mentally incapable patients
  12. Other malignant diseases except non- melanoma skin cancer, in situ carcinoma of the cervix, incidental prostate cancer (T1a, Gleason less than or equal to 6, prostate specific antigen (PSA) less than 0.5 ng/ml) or any other tumour having received adequate treatment and evidencing a disease-free period greater than or equal to 5 years
  13. Receiving chronic therapy for more than 10 days at doses of prednisone greater than 10 mg/day (or equivalent) at the moment of the inclusion. Inhaled and topical corticosteroids are allowed.
  14. Active hepatitis C or positive tests for human immunodeficiency virus (HIV)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460472


Locations
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Sponsors and Collaborators
Recombio SL
CIMAB (Cuba)
Laboratorio Elea Phoenix S.A.
Innogene Kalbiotech Pte. Ltd
Eurofarma Laboratorios S.A.
Investigators
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Study Director: Roberto Gomez, M.D. Recombio S.L.
More Information
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Responsible Party: Recombio SL
ClinicalTrials.gov Identifier: NCT01460472    
Other Study ID Numbers: EC-AR-1E10 MAb-301
ISRCTN47153584 ( Registry Identifier: International Clinical Trials Register Platform (ICTRP), WHO )
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Keywords provided by Recombio SL:
NSCLC
Lung cancer, small-cell
advanced lung cancer
 therapeutic vaccine
anti-idiotypic vaccine
1E10
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms