Know Cancer

or
forgot password

In Vivo Responses of DC Vaccines Presenting HLA Class I and II Restricted Tumor Epitopes Either by Peptide-pulsing or mRNA Transfection in Melanoma Patients


Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Both
Melanoma Stage III or IV

Thank you

Trial Information

In Vivo Responses of DC Vaccines Presenting HLA Class I and II Restricted Tumor Epitopes Either by Peptide-pulsing or mRNA Transfection in Melanoma Patients


Inclusion Criteria:



For both stage III and IV

- Histological proof of cutaneous melanoma

- Melanoma expressing both gp100 and tyrosinase, each in approximately 20% or more of
cells by immunohistochemistry staining,

- HLA type A2 and/or A3, with known HLA-DR4 expression,

- WBC > 3.0 x 109/l, lymphocytes > 0.8 x 109/l, platelets > 100 x 109/l, serum
creatinine < 150 μmol/l, serum bilirubin < 25 μmol/l.

- Expected adequacy of follow-up,

- Written informed consent.

For Stage III only

- Stage III melanoma according to the 2001 AJCC criteria.

- Start of treatment within 2 months of lymph node dissection for melanoma stage III

For stage IV only

-Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH < 2x
upper limit of normal

Exclusion Criteria:

For both stage III and IV

- No autoimmune disorders, no concomitant use of immunosuppressive drugs,

- no serious concomitant disease, no serious active infections, no other malignancy in
the past 5 years with the exception of curatively treated carcinoma in-situ of the
cervix/squamous cell carcinoma of the skin,

- No known allergy to shell fish (contains KLH) are excluded.

- No pregnancy or lactation,

For stage III only:

- No signs or symptoms of distant metastases as defined by normal history, physical
examination, chest X-ray and serum LDH.

- No concomitant or previous systemic treatment for melanoma

For stage IV only:

- No clinical signs of CNS metastases, in patients with a clinical suspicion of CNS
metastases, a CT scan of the brain should be performed to exclude this.

- No prior chemotherapy, immunotherapy, or radiotherapy within three months before
planned vaccination is allowed.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Immune response

Outcome Time Frame:

first 10 years

Safety Issue:

No

Principal Investigator

Prof. C.J.A. Punt, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University Nijmegen Medical Center

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

2003-2917

NCT ID:

NCT00243529

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Melanoma Stage III or IV
  • Dendritic cells
  • Melanoma
  • Vaccine
  • Immunotherapy
  • RNA
  • Peptides
  • Melanoma

Name

Location