Phase II/III Clinical Study CSF470 Plus BCG Plus GM-CSF vs IFN Alpha 2b in

Status Recruiting

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

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01729663
Study type	Interventional
Source	Laboratorio Pablo Cassará S.R.L.
Contact	José Mordoh, MD, PhD
Phone	54-11-6323-2900
Email	jmordoh@alexanderfleming.org
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	April 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05059444` - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Terminated	`NCT04042480` - A Study of SGN-CD228A in Advanced Solid Tumors	Phase 1
Recruiting	`NCT04020809` - Neoadjuvant Atezolizumab in Cutaneous Melanoma	Phase 1
Completed	`NCT03620019` - Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma	Phase 2
Recruiting	`NCT03767348` - Study of RP1 Monotherapy and RP1 in Combination With Nivolumab	Phase 2
Completed	`NCT03628417` - Confirmatory Trial in the Evaluation of Ca Electroporation for the Treatment of Cutaneous Metastases	N/A
Withdrawn	`NCT05482074` - Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2	Phase 2
Recruiting	`NCT05970497` - A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors	Phase 1
Completed	`NCT04551352` - A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas	Phase 1
Recruiting	`NCT05544929` - A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers	Phase 1
Recruiting	`NCT05628883` - Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma	Phase 1
Terminated	`NCT04254107` - A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer	Phase 1
Recruiting	`NCT04830124` - Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma - ARTISTRY-6	Phase 2
Recruiting	`NCT03699995` - MoleMapper, Visiomed, and Confocal Microscopy in Screening Participants for Melanoma	N/A
Recruiting	`NCT06319196` - Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma	Phase 2
Recruiting	`NCT05253872` - The MELAcare Study: A New Method for Surveillance of Melanoma Patients	N/A
Recruiting	`NCT04706962` - TH1902 in Patients With Advanced Solid Tumors	Phase 1
Recruiting	`NCT04792463` - Frequency and Clinical Phenotype of BAP1 Hereditary Predisposition Syndrome
Completed	`NCT00679289` - Phase II Study of KW2871 Combined With High Dose Interferon-α2b in Patients With Metastatic Melanoma	Phase 2
Recruiting	`NCT05669430` - A Study of GV20-0251 in Patients With Solid Tumor Malignancies	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms