Biological Therapy in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00002786
First received: November 1, 1999
Last updated: May 6, 2010
Last verified: May 2010
  Purpose

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.

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


Condition Intervention Phase
Melanoma (Skin)
Biological: aldesleukin
Biological: therapeutic tumor infiltrating lymphocytes
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: PHASE I STUDY TO EVALUATE THE SAFETY OF CELLULAR ADOPTIVE IMMUNOTHERAPY USING GENETICALLY MODIFIED AND UNMODIFIED AUTOLOGOUS CD8+ TYROSINASE-SPECIFIC T CELLS FOR PATIENTS WITH METASTATIC MELANOMA

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Estimated Enrollment: 20
Study Start Date: October 1995
Study Completion Date: March 2006
Detailed Description:

OBJECTIVES:

  • Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+ antigen-specific T-cell clones in patients with metastatic melanoma.
  • Estimate the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific cytotoxic T-cell clones in these patients.
  • Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these patients.

OUTLINE: Autologous peripheral blood mononuclear cells are harvested and then CD8+ cytotoxic T-lymphocyte (CTL) clones targeting melanosomal antigens are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-3. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for approximately 1 year after the last infusion.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histopathologically proven metastatic melanoma

    • No CNS metastases
  • HLA-A2 positive
  • Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging (x-ray, CT scan, or MRI)
  • Surgically accessible site for tumor cell procurement (skin, subcutaneous nodule, or superficial node) and patient clinically eligible for such surgery

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • Karnofsky 80-100%

Life expectancy

  • More than 16 weeks

Hematopoietic

  • WBC greater than 4,000/mm^3
  • Absolute neutrophil count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hematocrit greater than 30%

Hepatic

  • Bilirubin no greater than 1.6 mg/dL
  • SGOT no greater than 150 IU (or no greater than 3 times normal)
  • Prothrombin time no greater than 1.5 times control

Renal

  • Creatinine no greater than 2.0 mg/dL
  • Calcium no greater than 12 mg/dL

Cardiovascular

  • No congestive heart failure
  • No clinically significant hypotension
  • No symptoms of coronary artery disease
  • No arrhythmia on EKG requiring drug therapy

Pulmonary

  • No severe chronic obstructive pulmonary disease
  • FEV_1 at least 1.0 L
  • DLCO at least 45% of predicted

Other

  • No active infection or oral temperature greater than 38.2 degrees C within 72 hours of study
  • No systemic infection requiring chronic maintenance or suppressive therapy
  • HIV negative
  • No history of seizures
  • No retinitis or choroiditis
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use adequate contraception
  • Peripheral blood samples available weekly for 4 consecutive weeks

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since other prior immunotherapy

Chemotherapy

  • 1 or 2 courses of cytoreductive chemotherapy allowed for bulky disease
  • At least 4 weeks since prior standard or investigational chemotherapy

Endocrine therapy

  • At least 4 weeks since prior steroid therapy

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • At least 4 weeks since other prior investigational drug therapy and recovered
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002786

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002786     History of Changes
Obsolete Identifiers: NCT00029419
Other Study ID Numbers: 1017.01, FHCRC-1017.01, NCI-V96-0920, CDR0000064846
Study First Received: November 1, 1999
Last Updated: May 6, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
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
Aldesleukin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 23, 2014