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A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer Clinical research trials and A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 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 Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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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 Renal Cell Carcinoma Studies:
1. Immunization of Patients with Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
2. A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Postoperative Hepatic Arterial Chemotherapy Infusion for Metastatic Unresectable Colorectal Cancers of the Liver
3. Phase II trial of oral study drug in patients with advanced metastatic breast cancer who have experienced failure of an anthracycline, a taxane, and capecitabine
4. A Phase I Study of Weekly Gemcitabine Given in Combination with Infusional Fluorouracil and Oral and Intravenous Calcium Leucovorin in Adult Cancer Patients
5. Immunization of Patients with Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
Related Studies:
Other Renal Cell Carcinoma 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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