Biological Therapy in Treating Patients With Metastatic Melanoma

May 6, 2010 updated by: Fred Hutchinson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1995

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

May 23, 2003

First Posted (Estimate)

May 26, 2003

Study Record Updates

Last Update Posted (Estimate)

May 10, 2010

Last Update Submitted That Met QC Criteria

May 6, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1017.01
  • FHCRC-1017.01
  • NCI-V96-0920
  • CDR0000064846 (Registry Identifier: PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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