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Phase I Clinical Trial of a Therapeutic Vaccine Composed of Autologous Dendritic Cells Loaded With Allogeneic Apoptotic Tumor Cells in Patients With Melanoma Stages IIB, IIC, III and IV


Phase 1
17 Years
60 Years
Not Enrolling
Both
Melanoma

Thank you

Trial Information

Phase I Clinical Trial of a Therapeutic Vaccine Composed of Autologous Dendritic Cells Loaded With Allogeneic Apoptotic Tumor Cells in Patients With Melanoma Stages IIB, IIC, III and IV


Inclusion Criteria:



- histologically confirmed cutaneous melanoma stages IIB, IIC, III or IV (AJCC)

- pts with minimal or 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

- ages:from 15 to 60 years

- performance status (ECOG) 0 or 1

- pts with stage III disease had to be previously treated with IFN-alpha, and either
finished the treatment or suspended it due to disease progression, toxicity or other
clinical reasons. Alternatively, those pts who had not started IFN-alpha within six
months after surgery could be included in this study

- a suitable venous access for the leukapheresis procedure

- laboratory eligibility criteria included: hemoglobin > 10 gr %; WBC count > 4800/mm3,
platelets > 150.000/mm3, total and direct bilirubin, serum oxalacetic transaminase
and glutamic pyruvic transaminase < 1.5 fold the upper normal value; LDH < 450 mU/ml

- absence of pregnancy, with serum βHCG determined one week before vaccination in
premenopausal women

- serum creatinine < 1.4 mg %

- no chemotherapy, radiotherapy or any biological treatments during the previous month

- no concurrent medication with corticosteroids or NSAIDs

- l no active brain metastases m- normal ECG

- all pts gave written informed consent before inclusion in the Study.

Exclusion Criteria:

- Ocular melanoma or melanoma of mucosa

- Active brain metastases

- Other previous carcinoma (with the exeption of cervical or in situ basal cells
carcinoma adequately treated)

- Pregnant or breast-feeding women

- Cardiac Arythmia, severe heart disease.

- Bacterial, mycotic or viral serious infections ( > grade 2 according to NCI common
toxicity criteria)

- HIV, B or C Hepatitis previous infection

- Primary or secondary immunodeficiencies

- Other diseases that require treatment with regular corticoids or non steroids
anti-inflammatory drugs or COX-2 inhibitors

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Toxicity measured according to the NCI-Common Toxicity Criteria.

Outcome Time Frame:

115 days follow up per Subject (Trial duration)

Principal Investigator

José Mordoh, MD,PhD

Investigator Role:

Study Director

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

4484/04

NCT ID:

NCT00515983

Start Date:

October 2004

Completion Date:

December 2005

Related Keywords:

  • Melanoma
  • melanoma
  • dendritic cells
  • apoptotic/necrotic cells
  • therapeutic vaccine
  • Melanoma

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