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

Cutaneous Melanoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01729663
• Other study ID #: CASVAC0401
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 14, 2012
• Last updated: August 31, 2015
• Start date: April 2009

Study information

• Verified date: August 2015
• Source: Laboratorio Pablo Cassará S.R.L.
• Contact: José Mordoh, MD, PhD
• Phone: 54-11-6323-2900
• Email: jmordoh[@]alexanderfleming.org
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Melanoma
• Melanoma

Intervention

Biological:
• CSF470 vaccine, BCG, Molgramostim

Drug:
• interferon alpha 2b

Locations

Country	Name	City	State
Argentina	Instituto Médico Alexander Fleming	Buenos Aires	Capital Federal

Sponsors (6)

Lead Sponsor	Collaborator
Laboratorio Pablo Cassará S.R.L.	Agencia Nacional de Promocion Cientifica y Tecnica, Argentina, Fundacion Cancer FUCA, Fundacion Sales, Instituto Nacional del Cáncer, Argentina, National Council of Scientific and Technical Research, Argentina

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	OS, DFS, Partial or total remission (PR or CR)	two years	No
Primary	security	measured according to the NCI-Common Toxicity Criteria	two years	Yes
Secondary	Quality of Life	QOL:evaluated with EORTC QLQ-C30 questionnaire; ECOG Performance status	two years	No
Secondary	Induction of immune responses	Induction of immune responses associated to different vaccine doses for 2 years (Trial duration) ]Cellular immunity (DTH) - Humoral immunity	two years	No