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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


Phase 2/Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Cutaneous Melanoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy

Outcome Description:

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

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

José Mordoh, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto Médico Alexander Fleming

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

CASVAC0401

NCT ID:

NCT01729663

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Cutaneous Melanoma
  • melanoma
  • irradiated-allogeneic cells
  • therapeutic vaccine
  • Interferon alpha 2-b
  • Melanoma
  • Skin Neoplasms

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