We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vaccine Therapy in Treating Patients With High-Risk Stage III or Completely Resected Metastatic Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00019890
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: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have high-risk stage III or completely resected metastatic melanoma.


Condition Intervention Phase
Stage IV Melanoma Stage III Melanoma Recurrent Melanoma Drug: dendritic cell-gp100-MART-1 antigen vaccine Drug: sargramostim Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Randomized Study of CD34+ Derived or Peripheral Monocyte Derived Dendritic Cells Pulsed With MART-1 and gp100 Melanoma Antigens in Patients With High Risk Stage III or Completely Resected Metastatic Melanoma

Resource links provided by NLM:


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

Study Completion Date: March 2007
Detailed Description:

OBJECTIVES:

I. Determine the immunologic activity of CD34+ derived and peripheral monocyte derived dendritic cells pulsed with MART-1 and gp100 melanoma antigens in patients with high risk stage III or completely resected metastatic melanoma.

PROTOCOL OUTLINE: This is a randomized study. Patients receive dendritic cells derived either from peripheral monocytes or CD34+ cells.

Dendritic cells are pulsed with MART-1 and gp100 immunodominant HLA-A201 peptides prior to infusion, and are administered intralymphatically in the lower extremities for the first 2 courses. Beginning with courses 3 and 4, dendritic cells are administered subcutaneously in the anterior thigh. Dendritic cells are not administered to any extremity that has undergone lymph node dissection.

Patients are randomized to the following treatment arms:

Arm I: Patients undergo leukapheresis to obtain peripheral monocytes. Patients receive dendritic cells derived from peripheral mononuclear cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses.

Arm II: Patients receive 5 daily subcutaneous injections of filgrastim (G-CSF) followed by leukapheresis on days 5 and/or 6. Patients receive dendritic cells derived from CD34+ cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses.

Patients are followed at 4 to 6 weeks.

PROJECTED ACCRUAL:

A maximum of 28 patients (14 per treatment arm) will be accrued for this study within 7 months.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- High risk stage III melanoma (greater than 3 lymph nodes positive) OR completely resected metastatic melanoma within 6 months of surgery Disease free by CT scan HLA-A201 positive --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior biologic therapy No prior MART-1 or gp100 peptide immunization No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy No concurrent systemic steroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics No concurrent surgery --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL AST or ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiac disease Pulmonary: No major pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception No active systemic infection No autoimmune disorders HIV negative Hepatitis B surface antigen negative

  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): NCT00019890


Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: Patrick Hwu National Cancer Institute (NCI)
  More Information

ClinicalTrials.gov Identifier: NCT00019890     History of Changes
Obsolete Identifiers: NCT00001825
Other Study ID Numbers: CDR0000067277
NCI-99-C-0132
First Submitted: March 2, 2007
First Posted: March 5, 2007
Last Update Posted: June 20, 2013
Last Verified: June 2001

Keywords provided by National Cancer Institute (NCI):
adult solid tumor
body system/site cancer
cancer
melanoma
recurrent melanoma
skin tumor
solid tumor
stage III melanoma
stage IV melanoma
stage, melanoma

Additional relevant MeSH terms:
Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Vaccines
Immunologic Factors
Physiological Effects of Drugs