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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019396 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stage IV Melanoma Stage IV Renal Cell Cancer Recurrent Renal Cell Cancer Recurrent Melanoma |
Drug: flt3 ligand Drug: gp100 antigen Drug: MART-1 antigen Drug: Montanide ISA-51 Drug: tyrosinase peptide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of Flt3 Ligand Alone or in Combination With Melanoma Peptide Immunization in Patients With Metastatic Melanoma or Renal Cell Cancer |
| Study Start Date: | February 1998 |
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.
EligibilityPROTOCOL 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
Contacts and Locations More Information
| Study ID Numbers: | CDR0000065997, NCI-98-C-0040, NCI-T97-0092 |
| Study First Received: | March 1, 2007 |
| Last Updated: | March 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00019396 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Flt3 ligand protein Radiation-Protective Agents Disease Attributes Immunologic Factors Neoplasms, Nerve Tissue Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Melanoma Neoplasms by Site Pathologic Processes Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal |
Nevi and Melanomas Kidney Diseases Neoplasms by Histologic Type Adjuvants, Immunologic Protective Agents Pharmacologic Actions Recurrence Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Carcinoma, Renal Cell Adenocarcinoma Neoplasms, Glandular and Epithelial |
