flt3L With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma or Renal Cell Cancer

NCT00019396 | Completed Phase 2

• 3 other identifiers: CDR0000065997NCI-98-C-0040NCI-T97-0092
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IV Melanoma; Stage IV Renal Cell Cancer; Recurrent Renal Cell Cancer; Recurrent Melanoma

Keywords

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

Interventions

flt3 ligand DRUG

gp100 antigen DRUG

MART-1 antigen DRUG

Montanide ISA-51 DRUG

tyrosinase peptide DRUG

Eligibility Criteria

• Sex: all
• Age Groups: Child (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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Surgery Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Melanoma; Carcinoma, Renal Cell; Neoplasms; Urologic Neoplasms; Skin Neoplasms

Interventions

flt3 ligand protein; MART-1 Antigen; montanide ISA 51

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; 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 Antigens; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens, Neoplasm; Antigens; Biological Factors

Study Officials

• Patrick Hwu

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 5, 2007
• Study Start: February 1, 1998
• Study Completion: March 1, 2007
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

US (1)