Know Cancer

forgot password

Phase I/II Clinical Trial for the Evaluation of the Interaction Between Chemotherapy and Immunotherapy in Melanoma Patients

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

Phase I/II Clinical Trial for the Evaluation of the Interaction Between Chemotherapy and Immunotherapy in Melanoma Patients

Recently, it is becoming increasingly accepted that, in order to induce a clinically
effective antitumor response, immunotherapy needs to be combined with chemotherapy. Thus,
the traditional perception that chemotherapy and immunotherapy act through unrelated
mechanisms which may be antagonistic is challenged on the premises that a selected panel of
drugs can induce an immunogenic cell death producing specific danger signals. Furthermore,
chemotherapy combined to immunotherapy may affect antigen cross-presentation, induce a
"cytokine storm", reduce the number of regulatory T cells and activate homeostatic lymphoid
proliferation. Our previous results obtained in a mouse model, demonstrated that
drug-induced cytokines can favour antitumor immunity. Based on this observation, we explored
whether the administration of dacarbazine (DTIC) in disease-free melanoma patients in
combination with peptide vaccination could result into an improved anti tumor immune

Patients included in the study were assigned to two treatment arms either receiving
anti-tumor vaccination with Melan-A and gp100 analog peptides alone (arm 1) or in
combination with DTIC pre-treatment (arm 2).

Arm 1, vaccine alone: patients received i.d. injections of Melan-A: 26-35 (A27L) and gp100:
209-217 (210M) peptides (250 µg each) formulated in Montanide ISA-51 plus s.c. injection of
3MU IFN-α, as an adjuvant on day 1 and 8 every 21 days for a total of 5 courses (10
vaccinations). Both peptides and IFN-α were injected in close but separate sites next to
local lymph nodes.

Arm 2, DTIC plus vaccine: the same vaccination schedule was combined with DTIC (800 mg/mq
i.v.) administered one day before each vaccine administration according to the standard

Inclusion Criteria:

- histologically proven diagnosis of melanoma stage II, III, and IV without
clinical/radiological evidence of disease

- Age >18 years

- life expectancy of more than 6 months

- ECOG performance status of 0-2

- adequate blood cell counts and kidney-liver function

- use of adequate contraceptive methods

- signed informed consent

Exclusion Criteria:

- concomitant or previous history of malignant disease, except for in situ cervical
carcinoma or non melanomatous skin cancer

- severe cardiovascular disease

- clinically active infections and/or significant autoimmune diseases

- concomitant or previous (within 6 weeks) treatment with immunosuppressive drugs

- previous treatments with chemotherapy and/or interferon alpha or beta within 4 weeks
and/or radiotherapy within 6 weeks an/or biological therapy within 8 weeks before
starting vaccination

- psychiatric illness interfering with patient compliance, pregnancy or lactation

Type of Study:


Study Design:

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

Outcome Measure:

Assessment of safety by evaluating local and systemic adverse reactions during the trial. Assessment of the vaccine-specific cellular immune responses

Outcome Time Frame:

one year

Principal Investigator

Virginia Ferraresi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Regina Elena Cancer Institute


Italy: The Italian Medicines Agency

Study ID:




Start Date:

September 2004

Completion Date:

September 2006

Related Keywords:

  • Melanoma
  • Melanoma