NCT01729663

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

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

9.7 years

First QC Date

November 14, 2012

Last Update Submit

August 31, 2015

Conditions

Cutaneous Melanoma

Keywords

melanomairradiated-allogeneic cellstherapeutic vaccineInterferon alpha 2-b

Outcome Measures

Primary Outcomes (2)

  • Efficacy

    OS, DFS, Partial or total remission (PR or CR)

    two years

  • security

    measured according to the NCI-Common Toxicity Criteria

    two years

Secondary Outcomes (2)

  • Quality of Life

    two years

  • Induction of immune responses

    two years

Study Arms (2)

Interferon alpha 2 b

ACTIVE COMPARATOR

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

CSF470 vaccine, BCG, Molgramostim

EXPERIMENTAL

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

Interventions

CSF470 vaccine, BCG, MolgramostimBIOLOGICAL
CSF470 vaccine, BCG, Molgramostim
interferon alpha 2bDRUG
Interferon alpha 2 b

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 %

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Médico Alexander Fleming

Buenos Aires, Buenos Aires F.D., 1426, Argentina

RECRUITING

Related Publications (2)

  • Aris M, Bravo AI, Pampena MB, Blanco PA, Carri I, Koile D, Yankilevich P, Levy EM, Barrio MM, Mordoh J. Changes in the TCRbeta Repertoire and Tumor Immune Signature From a Cutaneous Melanoma Patient Immunized With the CSF-470 Vaccine: A Case Report. Front Immunol. 2018 May 3;9:955. doi: 10.3389/fimmu.2018.00955. eCollection 2018.

    PMID: 29774030DERIVED

  • Mordoh J, Pampena MB, Aris M, Blanco PA, Lombardo M, von Euw EM, Mac Keon S, Yepez Crow M, Bravo AI, O'Connor JM, Orlando AG, Ramello F, Levy EM, Barrio MM. Phase II Study of Adjuvant Immunotherapy with the CSF-470 Vaccine Plus Bacillus Calmette-Guerin Plus Recombinant Human Granulocyte Macrophage-Colony Stimulating Factor vs Medium-Dose Interferon Alpha 2B in Stages IIB, IIC, and III Cutaneous Melanoma Patients: A Single Institution, Randomized Study. Front Immunol. 2017 May 31;8:625. doi: 10.3389/fimmu.2017.00625. eCollection 2017.

    PMID: 28620382DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

molgramostimInterferon alpha-2

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • José Mordoh, MD, PhD

    Instituto Médico Alexander Fleming

    PRINCIPAL INVESTIGATOR

Central Study Contacts

José Mordoh, MD, PhD

CONTACT

54-11-6323-2900jmordoh@alexanderfleming.org

María M Barrio, PhD

CONTACT

54-11-6323-2900barrio.marcela@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 20, 2012

Study Start

April 1, 2009

Primary Completion

December 1, 2018

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations

AR(1)