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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00019396
First Posted: March 5, 2007
Last Update Posted: June 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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 2

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 1998
Study Completion Date: March 2007
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Maryland
Surgery Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: Patrick Hwu National Cancer Institute (NCI)
  More Information

ClinicalTrials.gov Identifier: NCT00019396     History of Changes
Obsolete Identifiers: NCT00001687
Other Study ID Numbers: CDR0000065997
NCI-98-C-0040
NCI-T97-0092
First Submitted: March 1, 2007
First Posted: March 5, 2007
Last Update Posted: June 20, 2013
Last Verified: May 2006

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Melanoma
Carcinoma, Renal Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Flt3 ligand protein
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents