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Biological Therapy in Treating Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045149
  Purpose

RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's white blood cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells.

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


Condition Intervention Phase
Melanoma (Skin)
Drug: aldesleukin
Drug: therapeutic tumor infiltrating lymphocytes
Phase I

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Aldesleukin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen Specific T Cell Clones Targeting Cancer Testis Antigens for Patients With Metastatic Melanoma

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

Study Start Date: October 2002
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety and toxicity of cellular adoptive immunotherapy comprising autologous CD8+ cytotoxic T-lymphocyte clones targeting cancer-testis antigens in patients with metastatic melanoma.
  • Determine the duration of in vivo persistence of this therapy in these patients.

Secondary

  • Evaluate the antitumor effects of this therapy in these patients.

OUTLINE: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and then CD8+ cytotoxic T-lymphocyte (CTL) clones are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones targeting cancer testis antigens IV over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-4. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a clinical response after completion of the fourth course are eligible to receive additional T-cell infusions.

Patients are followed for 9 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic melanoma

    • Stage IV disease
  • HLA-A1, -A2, and -A3 positive
  • MAGE-1 or -3 positive by histology
  • Bidimensionally measurable disease by palpation on clinical examination, x-ray, or CT scan
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • Karnofsky 80-100%

Life expectancy

  • More than 6 months

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin ≤ 1.6 mg/dL
  • SGOT ≤ 3 times upper limit of normal
  • PT ≤ 1.5 times control

Renal

  • Creatinine ≤ 2.0 mg/dL
  • Calcium ≤ 12 mg/dL

Cardiovascular

  • No congestive heart failure
  • No clinically significant hypotension
  • No symptoms of coronary artery disease
  • No cardiac arrhythmias on electrocardiogram requiring drug therapy
  • Patients with prior cardiovascular disease or the presence of any of the above abnormalities undergo a cardiac evaluation, which may include a stress test and/or echocardiogram

Pulmonary

  • No clinically significant pulmonary dysfunction by medical history or physical examination
  • FEV_1 ≥ 60% of normal
  • DLCO ≥ 55% (corrected for hemoglobin)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No retinitis or choroiditis
  • No active infections or oral temperature greater than 38.2 degrees Celsius within the past 72 hours
  • No systemic infection requiring chronic maintenance or suppressive therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No other concurrent immunotherapy (e.g., other interleukins, interferons, melanoma vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy)

Chemotherapy

  • At least 3 weeks since prior standard or experimental chemotherapy
  • 1-2 courses of prior cytoreductive chemotherapy for bulky disease allowed

Endocrine therapy

  • No concurrent systemic steroids (except for toxicity management)

Radiotherapy

  • At least 3 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • At least 3 weeks since prior immunosuppressive therapy
  • No concurrent pentoxifylline
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045149

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Cassian Yee, MD Fred Hutchinson Cancer Research Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000256451, FHCRC-1588.00, NCI-H02-0091
Study First Received: September 6, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00045149  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Neuroectodermal Tumors
Aldesleukin
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Testicular Diseases
Neuroepithelioma
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms
Anti-HIV Agents
Neoplasms by Histologic Type
Anti-Retroviral Agents
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009