flt3L With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma or Renal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT00019396|
Recruitment Status : Completed
First Posted : March 5, 2007
Last Update Posted : June 20, 2013
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 or disease||Intervention/treatment||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 2|
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.
Approximately 54-96 patients (18-32 per treatment group) will be accrued for this study within 16 months.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Study Completion Date :||March 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019396
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Patrick Hwu||National Cancer Institute (NCI)|