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Home > "A" Clinical Trials Conditions > A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer  A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer
A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer
For Condition: Melanoma,Neoplasm Metastasis,Renal Cell Carcinoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients with metastatic melanoma and renal cell cancer will be treated with Flt3 ligand (Flt3L). In addition, melanoma patients will be treated with the immunodominant peptide GP100:209-217 (210M) from the melanoma GP100 antigen in combination with Flt3L. This study is designed to evaluate the immunologic and biologic effects of Flt3L in the presence and absence of immunization with the GP100:209-217 (210) peptide.
Details: Patients with metastatic melanoma and renal cell cancer will be treated with Flt3 ligand (Flt3L). In addition, melanoma patients will be treated with peptides representing HLA-A0201 restricted T cell epitopes of the melanoma antigens, MART-1, gp100 and tyrosinase, emulsified in Incomplete Freund's Adjuvant, (IFA) in combination with Flt3L. This study is designed to evaluate the immunologic and biologic effects of Flt3L in the presence and absence of immunization with melanoma peptide antigens.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Any patient with metastatic melanoma or renal cancer with disease that is measurable and an expected survival of greater than three months will be considered. (Patients to receive GP100:209-217 (210M) peptide must be HLA-A201.) Eligibility requirements include the following: Serum creatinine of 2.0 mg/dl or less. Bilirubin 1.6 mg/dl or less. WBC 3000/ mm(3) or greater. Platelet count 90,000 mm(3) or greater. Serum AST/ALT less than two times normal. ECOG performance status of 0 or 1. EXCLUSION CRITERIA: Patients will be excluded: Who are undergoing or have undergone in the past month any other form of therapy except surgery for their cancer. Who have active systemic infections, coagulation disorders, history of autoimmune disorders or other major medical illnesses of the cardiovascular or respiratory systems. Who require systemic steroid therapy. Who are pregnant (because of possible side effects on the fetus) and/or breast feeding. Who are known to be positive for hepatitis B(s)Ag, or HIV antibody (because of possible immune effects of these conditions). Who have had a known allergic reaction to Incomplete Freund's Adjuvant (IFA).
Total Enrollment: 96
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980040; 98-C-0040
Study Start Date: December 22, 1997
Record last reviewed: March 8, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001687
Other Neoplasm Metastasis Studies:
1. Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
2. Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
3. A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion with Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients with Locally Advanced Extremity Melanoma
4. Vaccine Treatment for Advanced Melanoma
5. EPO906 Therapy in Patients with Advanced Melanoma
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Maryland Clinical Trials
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A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer
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