Phase II Randomized Study of CD34+ Derived or Peripheral Monocyte Derived Dendritic Cells Pulsed With MART-1 and gp100 Melanoma Antigens in Patients With High Risk Stage III or Completely Resected Metastatic Melanoma


Phase 2
16 Years
N/A
Not Enrolling
Both
Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma

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Trial Information

Phase II Randomized Study of CD34+ Derived or Peripheral Monocyte Derived Dendritic Cells Pulsed With MART-1 and gp100 Melanoma Antigens in Patients With High Risk Stage III or Completely Resected Metastatic Melanoma


OBJECTIVES:

I. Determine the immunologic activity of CD34+ derived and peripheral monocyte derived
dendritic cells pulsed with MART-1 and gp100 melanoma antigens in patients with high risk
stage III or completely resected metastatic melanoma.

PROTOCOL OUTLINE: This is a randomized study. Patients receive dendritic cells derived
either from peripheral monocytes or CD34+ cells.

Dendritic cells are pulsed with MART-1 and gp100 immunodominant HLA-A201 peptides prior to
infusion, and are administered intralymphatically in the lower extremities for the first 2
courses. Beginning with courses 3 and 4, dendritic cells are administered subcutaneously in
the anterior thigh. Dendritic cells are not administered to any extremity that has undergone
lymph node dissection.

Patients are randomized to the following treatment arms:

Arm I: Patients undergo leukapheresis to obtain peripheral monocytes. Patients receive
dendritic cells derived from peripheral mononuclear cells pulsed with MART-1 and gp100 every
4 weeks for up to 4 courses.

Arm II: Patients receive 5 daily subcutaneous injections of filgrastim (G-CSF) followed by
leukapheresis on days 5 and/or 6. Patients receive dendritic cells derived from CD34+ cells
pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses.

Patients are followed at 4 to 6 weeks.

PROJECTED ACCRUAL:

A maximum of 28 patients (14 per treatment arm) will be accrued for this study within 7
months.

Inclusion Criteria


PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- High risk stage III melanoma (greater than 3 lymph nodes
positive) OR completely resected metastatic melanoma within 6 months of surgery Disease
free by CT scan HLA-A201 positive --Prior/Concurrent Therapy-- Biologic therapy: At least
4 weeks since prior biologic therapy No prior MART-1 or gp100 peptide immunization No
concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No
concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy
No concurrent systemic steroid therapy Radiotherapy: At least 4 weeks since prior
radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics No concurrent
surgery --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0-1 Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL AST or ALT
less than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL
Cardiovascular: No major cardiac disease Pulmonary: No major pulmonary disease Other: Not
pregnant or nursing Fertile patients must use effective contraception No active systemic
infection No autoimmune disorders HIV negative Hepatitis B surface antigen negative

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Patrick Hwu

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000067277

NCT ID:

NCT00019890

Start Date:

Completion Date:

March 2007

Related Keywords:

  • Stage IV Melanoma
  • Stage III Melanoma
  • Recurrent Melanoma
  • adult solid tumor
  • body system/site cancer
  • cancer
  • melanoma
  • recurrent melanoma
  • skin tumor
  • solid tumor
  • stage III melanoma
  • stage IV melanoma
  • stage, melanoma
  • Melanoma

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