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Vaccine Therapy in Treating Patients With Metastatic Melanoma - Article


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Melanoma

Melanoma cancer 




Clinical Trial: Vaccine Therapy in Treating Patients With Metastatic Melanoma

This study is no longer recruiting patients.

Sponsors and Collaborators: Baylor University
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 Treatment or Intervention Phase
Stage IV Melanoma
Recurrent Melanoma
 Drug: autologous dendritic cells
 Drug: filgrastim
 Procedure: biological response modifier therapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: non-tumor cell derivative vaccine
 Procedure: vaccine therapy
Phase I

MedlinePlus related topics:  Melanoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Antigen-Pulsed Dendritic Cell Vaccine in Patients With Metastatic Melanoma

Further Study Details: 

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

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both

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:


Location Information


Texas
      Baylor University Medical Center, Dallas,  Texas,  75246,  United States

Study chairs or principal investigators

Joseph Wayne Fay, MD,  Study Chair,  Baylor University   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068680; BAYUMC-000048; NCI-4170
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00017355
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 4, 2009



Page Updated: October 15, 2009
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