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Vaccine Therapy in Treating Patients With Metastatic Melanoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00017355
First Posted: January 27, 2003
Last Update Posted: September 17, 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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.


Condition Intervention Phase
Melanoma (Skin) Biological: filgrastim Biological: therapeutic autologous dendritic cells Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial

Resource links provided by NLM:


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

Study Start Date: April 2001
Detailed Description:

OBJECTIVES:

  • Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma.
  • Determine the longevity of melanoma-specific immunity in patients treated with this regimen.
  • Perform serial analysis of T-cell and B-cell function in patients treated with this regimen.

OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or 1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35, gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation.

Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression.

Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic melanoma
  • HLA-A2-01 phenotype
  • Measurable disease
  • No active CNS or hepatic metastases

PATIENT CHARACTERISTICS:

Age:

  • 21 and over

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • See Disease Characteristics
  • No viral hepatitis

Renal:

  • Not specified

Cardiovascular:

  • No prior venous thrombosis, angina pectoris, or congestive heart failure
  • Lactate dehydrogenase less than 2 times normal

Pulmonary:

  • No prior asthma

Immunologic:

  • Intradermal skin test positivity to mumps, Candida, or streptokinase antigen
  • No known sensitivity to E. coli drug preparations
  • No prior allergy to influenza vaccine
  • No active infection
  • No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis)

Other:

  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 8 weeks since prior interleukin-2
  • At least 4 weeks since prior interferon alfa

Chemotherapy:

  • At least 8 weeks since prior chemotherapy

Endocrine therapy:

  • At least 2 weeks since prior corticosteroids
  • No concurrent corticosteroids

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent immunosuppressive agents
  • At least 2 weeks since prior immunosuppressive agents
  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): NCT00017355


Locations
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Health Care System
National Cancer Institute (NCI)
Investigators
Study Chair: Joseph W. Fay, MD Baylor Health Care System
  More Information

ClinicalTrials.gov Identifier: NCT00017355     History of Changes
Other Study ID Numbers: CDR0000068680
BAYUMC-000048
NCI-4170
First Submitted: June 6, 2001
First Posted: January 27, 2003
Last Update Posted: September 17, 2013
Last Verified: March 2003

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas