This date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reported
Study Completion
March 2007
Actual (reported)
Brief Summary
RATIONALE: The drug flt3L may stimulate a person's immune system and help to kill tumor cells. Vaccines made from melanoma cells may make the body build an immune response to and kill their tumor cells.
PURPOSE: Phase II trial to study the effectiveness of flt3L with or without vaccine therapy in treating patients with metastatic melanoma or renal cell cancer.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Reported enrollment (type unavailable)
Not reported
Study completion date
March 2007
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
February 1998
Date type not reported
This date has not been verified as actual or estimated.
adult solid tumorbody system/site cancercancerkidney tumorkidney/urinary cancermelanomarecurrent melanomarecurrent renal cell cancerrenal cell cancerskin tumorsolid tumorstage IV melanomastage IV renal cell cancerstage, melanomastage, renal cell cancer
Interventions
flt3 ligandDrug
gp100 antigenDrug
MART-1 antigenDrug
Eligibility Criteria
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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
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Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Neoplasms by Site
Skin Diseases
Skin and Connective Tissue Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Intervention Hierarchy (Ancestors)
Melanoma-Specific AntigensNeoplasm ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigens, NeoplasmAntigensBiological Factors
Last Updated
March 4, 2024
Record last verified: 2024-02
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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