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Phase II Study of Flt3 Ligand Alone or in Combination With Melanoma Peptide Immunization in Patients With Metastatic Melanoma or Renal Cell Cancer


Phase 2
N/A
N/A
Not Enrolling
Both
Stage IV Melanoma, Stage IV Renal Cell Cancer, Recurrent Renal Cell Cancer, Recurrent Melanoma

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Trial Information

Phase II Study of Flt3 Ligand Alone or in Combination With Melanoma Peptide Immunization in Patients With Metastatic Melanoma or Renal Cell Cancer


OBJECTIVES: I. Evaluate the immunologic and biologic activity of flt3 ligand (Flt3L) alone
in patients with metastatic renal cell cancer or HLA-A2.1 negative melanoma.

II. Evaluate the immunologic and biologic activity of Flt3L alone or in combination with
melanoma peptide immunization (MART-1, gp100:209-217, gp100:280-288, and tyrosinase) in
patients with metastatic, HLA-A2.1 positive melanoma.

PROTOCOL OUTLINE: Patients are assigned to 1 of 3 treatment groups:

Group 1 (renal cell cancer): Patients receive Flt3 ligand (Flt3L) subcutaneously (SQ) alone
on days 1-14.

Group 2 (HLA-A2.1 negative melanoma): Patients receive Flt3L SQ alone on days 1-14.

Group 3 (HLA-A2.1 positive melanoma): Patients may receive either Flt3L SQ alone on days
1-14 or in combination with melanoma peptide immunization. Patients may receive melanoma
peptide immunization comprised of MART-1 immunodominant peptide, gp100:209-217,
gp100:280-288, and tyrosinase peptide emulsified in Montanide ISA-51 SQ on day 12 of Flt3L
administration.

Treatment repeats every 4 weeks for 2 courses. Patients with no response or minor response
may receive 2 additional courses. Patients with disease progression after 1 course are
removed from study.

PROJECTED ACCRUAL:

Approximately 54-96 patients (18-32 per treatment group) will be accrued for this study
within 16 months.

Inclusion Criteria


PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically proven metastatic melanoma or renal cell cancer
Patients receiving melanoma peptide immunizations must be HLA-A2.1 positive Measurable
disease --Prior/Concurrent Therapy-- Biologic therapy: At least 1 month since prior
biologic therapy Chemotherapy: At least 1 month since prior chemotherapy Endocrine
therapy: No concurrent systemic steroid therapy At least 1 month since prior steroid
therapy Radiotherapy: At least 1 month since prior radiotherapy Surgery: Prior surgery
allowed Other: Greater than 1 month since prior therapy --Patient Characteristics-- Age:
Not specified Performance Status: ECOG 0-1 Life Expectancy: Greater than 3 months
Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation
disorders Hepatic: Bilirubin no greater than 1.6 mg/dL AST and ALT less than 2 times
normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No major cardiovascular
disease Pulmonary: No major pulmonary disease Other: Not pregnant or nursing Negative
pregnancy test HIV negative Hepatitis B surface antigen negative No allergic reaction to
Montanide ISA-51 No active systemic infection No prior autoimmune disorders

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:

CDR0000065997

NCT ID:

NCT00019396

Start Date:

February 1998

Completion Date:

March 2007

Related Keywords:

  • Stage IV Melanoma
  • Stage IV Renal Cell Cancer
  • Recurrent Renal Cell Cancer
  • Recurrent Melanoma
  • adult solid tumor
  • body system/site cancer
  • cancer
  • kidney tumor
  • kidney/urinary cancer
  • melanoma
  • recurrent melanoma
  • recurrent renal cell cancer
  • renal cell cancer
  • skin tumor
  • solid tumor
  • stage IV melanoma
  • stage IV renal cell cancer
  • stage, melanoma
  • stage, renal cell cancer
  • Carcinoma, Renal Cell
  • Melanoma

Name

Location

Surgery BranchBethesda, Maryland  20892