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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.

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


Condition or disease Intervention/treatment Phase
Cutaneous Melanoma Biological: CSF470 vaccine, BCG, Molgramostim Drug: interferon alpha 2b Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2009
Estimated Primary Completion Date : December 2018


Arm Intervention/treatment
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.
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.

Biological: CSF470 vaccine, BCG, Molgramostim



Primary Outcome Measures :
  1. Efficacy [ Time Frame: two years ]
    OS, DFS, Partial or total remission (PR or CR)

  2. security [ Time Frame: two years ]
    measured according to the NCI-Common Toxicity Criteria


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: two years ]
    QOL:evaluated with EORTC QLQ-C30 questionnaire; ECOG Performance status

  2. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01729663


Contacts
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Contact: José Mordoh, MD, PhD 54-11-6323-2900 ext 2205 jmordoh@alexanderfleming.org
Contact: María M Barrio, PhD 54-11-6323-2900 ext 1110 barrio.marcela@gmail.com

Locations
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Argentina
Instituto Médico Alexander Fleming Recruiting
Buenos Aires, Capital Federal, Argentina, 1426
Contact: José Mordoh, MD, PhD    44-11-6323-2900 ext 2204    jmordoh@leloir.org.ar   
Principal Investigator: José Mordoh, MD, PhD         
Sub-Investigator: María M Barrio, PhD         
Sponsors and Collaborators
Laboratorio Pablo Cassará S.R.L.
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
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Principal Investigator: José Mordoh, MD, PhD Instituto Médico Alexander Fleming

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: José Mordoh, MD, PhD, Laboratorio Pablo Cassará S.R.L.
ClinicalTrials.gov Identifier: NCT01729663     History of Changes
Other Study ID Numbers: CASVAC0401
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
Keywords provided by José Mordoh, Laboratorio Pablo Cassará S.R.L.:
melanoma
irradiated-allogeneic cells
therapeutic vaccine
Interferon alpha 2-b
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferons
Interferon-alpha
Interferon alpha-2
Molgramostim
Vaccines
BCG Vaccine
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic