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A Phase I-II Trial of Antigen-Pulsed Autologous Dendritic Cells for Induction of Anti-Tumor Immunity in Patients Completing Lymphadenectomy for Metastatic Melanoma

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Phase I-II Trial of Antigen-Pulsed Autologous Dendritic Cells for Induction of Anti-Tumor Immunity in Patients Completing Lymphadenectomy for Metastatic Melanoma

OBJECTIVES: I. Determine the safety and toxicity of intravenous injections of autologous
cultured dendritic cells pulsed with either gp100 and tyrosinase peptides or autologous
melanoma tumor cell lysates in patients with metastatic melanoma. II. Determine whether
treatment with melanoma tumor antigen pulsed autologous dendritic cells results in increased
in vitro tumor specific cytotoxic T-cell responses. III. Determine whether this treatment
can induce positive skin test responses to tumor antigens. IV. Evaluate the disease free and
overall survival of these patients.

OUTLINE: This is a randomized, dose escalation study. Approximately 1-2 weeks following
surgical lymphadenectomy, patients undergo leukapheresis to collect dendritic cells and are
then divided into 3 groups. Group A consists of patients without adequate tumor for
preparation of tumor lysate and who have tumors that express tyrosinase or gp100 with types
HLA-A1, A2, or A3. Group B consists of the patients who have adequate tumor for lysate
preparation but who do not type for HLA-A1, A2, or A3 (required for the peptide pulsed
protocol). Group C are the patients with adequate tumor who are eligible for the peptide
pulsed protocol. Group A patients receive autologous dendritic cells pulsed with appropriate
peptide antigens. Group B patients are treated with autologous dendritic cells pulsed with
autologous tumor cell lysates. Group C patients are randomized to receive dendritic cells
pulsed with either peptide antigens or tumor lysate. All patients are administered
intravenous active immunotherapy for 4 monthly intervals. The dose of the immunizations is
escalated for each cohort of three patients that is accrued in each of the groups mentioned
above. Each immunization at each dose level is followed by three days of interleukin-2
administered subcutaneously twice daily. Patients are followed at least 5 years for

PROJECTED ACCRUAL: There will be 100 patients accrued in this study over 2 years. There will
be 50, 20, and 30 patients in groups A, B, and C, respectively.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma involving cervical,
axillary, inguinal, groin, or iliac lymph nodes All gross disease is resected at the time
of surgical lymphadenectomy No distant metastases

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-1 Life expectancy: At
least 6 months Hematopoietic: Platelet count at least 100,000/mm3 Hemoglobin at least 8
g/dL Hepatic: Bilirubin no greater than 1.4 mg/dL AST or ALT no greater than 1.5 times
normal No active hepatitis Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: No
congestive heart failure, unstable angina, or current symptomatic arrhythmias Other: HIV
negative No autoimmune diseases (e.g., lupus erythematosus, multiple sclerosis, or
ankylosing spondylitis) No condition that would be considered as a contraindication for
surgery Not pregnant or nursing Adequate contraception required for all fertile patients

PRIOR CONCURRENT THERAPY: At least 4 weeks since prior therapy for melanoma Biologic
therapy: At least 3 months since prior interferon therapy Chemotherapy: No active
immunosuppression due to prior chemotherapy Endocrine therapy: No active immunosuppression
due to steroid therapy Radiotherapy: Not specified Surgery: Not specified

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Hilliard F. Seigler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:




Start Date:

July 1997

Completion Date:

February 2005

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma



Duke Comprehensive Cancer Center Durham, North Carolina  27710
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908