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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01729663
Other study ID # CASVAC0401
Secondary ID
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. completion date
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


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
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