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Phase II/III Clinical Study CSF470 Plus BCG Plus GM-CSF vs IFN Alpha 2b in Stage IIB, IIC and III Melanoma Patients

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ClinicalTrials.gov Identifier: NCT01729663
Recruitment Status : Unknown
Verified August 2015 by José Mordoh, Laboratorio Pablo Cassará S.R.L..
Recruitment status was:  Recruiting
First Posted : November 20, 2012
Last Update Posted : September 2, 2015
Sponsor:
Collaborators:
Fundacion Sales
National Agency for Scientific and Technological Promotion, Argentina
Fundacion Cancer FUCA
National Council of Scientific and Technical Research, Argentina
Instituto Nacional del Cáncer, Argentina
Information provided by (Responsible Party):
José Mordoh, Laboratorio Pablo Cassará S.R.L.

Tracking Information
First Submitted Date  ICMJE November 14, 2012
First Posted Date  ICMJE November 20, 2012
Last Update Posted Date September 2, 2015
Study Start Date  ICMJE April 2009
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
  • Efficacy [ Time Frame: two years ]
    OS, DFS, Partial or total remission (PR or CR)
  • security [ Time Frame: two years ]
    measured according to the NCI-Common Toxicity Criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01729663 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
  • Quality of Life [ Time Frame: two years ]
    QOL:evaluated with EORTC QLQ-C30 questionnaire; ECOG Performance status
  • Induction of immune responses [ Time Frame: two years ]
    Induction of immune responses associated to different vaccine doses for 2 years (Trial duration) ]Cellular immunity (DTH) - Humoral immunity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II/III Clinical Study CSF470 Plus BCG Plus GM-CSF vs IFN Alpha 2b in Stage IIB, IIC and III Melanoma Patients
Official Title  ICMJE Randomized, Comparative Phase II/III Study Between Treatment With CSF470 Vaccine (Allogeneic, Irradiated) Plus BCG and MOLGRAMOSTIN (rhGM-CSF) as Adjuvants and Interferon-alfa 2b (IFN-ALPHA), in Stages IIB, IIC and III Post Surgery Cutaneous Melanoma Patients
Brief Summary

Randomized, open, Phase II-III study, comparative between treatment with CSF-470 vaccine , allogeneic, irradiated with BCG and molgramostin (rHuGM-CSF) as adjuvants and interferon alfa 2b (IFN-alpha2b) treatment , in stages IIB, IIC o III (AJCC) post-surgery cutaneous melanoma patients. This study has been approved by ANMAT ( Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT)), number 1556/2011 (www.anmat.gov.ar).

The study Institution is Instituto Médico Especializado Alexander Fleming, Ciudad Autónoma de Buenos Aires, Argentina. The Sponsor is Laboratory Pablo Cassará (LPC, S.R.L.).

Study population include a total of 108 patients (72 patients will receive CSF470 vaccine and 36 patients will receive alpha IFN-alpha 2b) for a total of 24 months.

CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then one dose every two months for the first year and them every three months for the second year.

Each vaccine consist of a mixture of 17,6.106 melanoma cells, from four melanoma cell lines, not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first day and rHuGM-CSF (Molgramostim, 400 µg, fractionated in four days doses) will be used.

IFN-alpha 2b treatment will consist of s.c. injection of 10 million units (MU) (5 t/w ) for four weeks and then 5 MU (3t/w) for 23 months.

Both treatments will also compare quality of life (QOL) and study a possible correlation in the CSF470 vaccine arm between the induced immune response and clinical outcome

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous Melanoma
Intervention  ICMJE
  • Biological: CSF470 vaccine, BCG, Molgramostim
  • Drug: interferon alpha 2b
Study Arms  ICMJE
  • Active Comparator: Interferon alpha 2 b
    Interferon alpha 2b treatment will consist of s.c. injection of 10 MU (5 t/w) for four weeks and then 5 MU (3t/w) for 23 months.
    Intervention: Drug: interferon alpha 2b
  • Experimental: CSF470 vaccine, BCG, Molgramostim

    CSF470 vaccine, BCG, Molgramostim

    CSF-470 treatment will consist of four vaccine doses id injection (three weeks apart), then one dose every two months for the first year and them every three months for the second year.

    Each vaccine consist of a mixture of 17,6.106 melanoma cells , from four melanoma cell lines, not genetically modified and lethally irradiated. As adjuvant BCG (120 µg prot) the first day and rhGM-CSF (Molgramostim 400 µg, fractionated in four days doses) will be used.

    Intervention: Biological: CSF470 vaccine, BCG, Molgramostim
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 19, 2012)
108
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • histologically confirmed cutaneous melanoma stages IIB, IIC or III (AJCC)
  • patients non-detectable disease (NED) after surgery as asserted by CAT scans. Melanoma pts with unknown primary tumor site could be included in the study
  • life expectancy > 6 months
  • performance status (ECOG) 0 or 1
  • Time post surgery not more than 4 months
  • no chemotherapy, radiotherapy or any biological treatments prior to this study.
  • patients must have CATscans of brain, thorax, abdomen and pelvis in the 60 previous days to trial enrolling
  • To have laboratory studies (no more than 15 days before entering the study)
  • laboratory eligibility criteria include: hematocrit: ≥35 (hemoglobin > 10,5 gr %); WBC count > 3500/mm3, platelets > 100.000/mm3, total and direct bilirubin, serum oxalacetic transaminase and glutamic pyruvic transaminase < 1.5 fold the upper normal value; LDH ≤ 450 mU/ml
  • negative serology for HIV, anti-HCV and HBsAg
  • serum creatinine < 2.0 mg %
  • all patients must give written informed consent before inclusion in the Study.

Exclusion Criteria:

  • Pregnant or breast-feeding women
  • Diabetes (Type I or II)
  • Antecedents of psychiatric diseases
  • Evidence of active infections
  • Antecedents of viral or autoimmune hepatitis
  • Previous autoimmune diseases
  • Morbid Obesity, defined as CMI (Corporal mass index)>37 kg/m2 in women and >40 kg/m2 in men.
  • Other diseases that require treatment with regular corticoids or non steroids anti-inflammatory drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01729663
Other Study ID Numbers  ICMJE CASVAC0401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party José Mordoh, Laboratorio Pablo Cassará S.R.L.
Study Sponsor  ICMJE Laboratorio Pablo Cassará S.R.L.
Collaborators  ICMJE
  • Fundacion Sales
  • National Agency for Scientific and Technological Promotion, Argentina
  • Fundacion Cancer FUCA
  • National Council of Scientific and Technical Research, Argentina
  • Instituto Nacional del Cáncer, Argentina
Investigators  ICMJE
Principal Investigator: José Mordoh, MD, PhD Instituto Médico Alexander Fleming
PRS Account Laboratorio Pablo Cassará S.R.L.
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP