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 |
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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
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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 |
| 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 |
|---|---|
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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.
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Drug: interferon alpha 2b |
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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 |
- Efficacy [ Time Frame: two years ]OS, DFS, Partial or total remission (PR or CR)
- security [ Time Frame: two years ]measured according to the NCI-Common Toxicity Criteria
- Quality of Life [ Time Frame: two years ]QOL:evaluated with EORTC QLQ-C30 questionnaire; ECOG Performance status
- 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 |
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
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
| 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 |
| 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 | |
| Principal Investigator: | José Mordoh, MD, PhD | Instituto Médico Alexander Fleming |
| Responsible Party: | José Mordoh, MD, PhD, Laboratorio Pablo Cassará S.R.L. |
| ClinicalTrials.gov Identifier: | NCT01729663 |
| Other Study ID Numbers: |
CASVAC0401 |
| First Posted: | November 20, 2012 Key Record Dates |
| Last Update Posted: | September 2, 2015 |
| Last Verified: | August 2015 |
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melanoma irradiated-allogeneic cells therapeutic vaccine Interferon alpha 2-b |
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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 Sargramostim BCG Vaccine Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic |