Phase II Study of Flt3 Ligand Alone or in Combination With Melanoma Peptide Immunization in Patients With Metastatic Melanoma or Renal Cell Cancer
N/A
N/A
Both
Stage IV Melanoma, Stage IV Renal Cell Cancer, Recurrent Renal Cell Cancer, Recurrent Melanoma
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 Branch | Bethesda, Maryland 20892 |
