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Biological Therapy in Treating Patients With Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
therapeutic tumor infiltrating lymphocytes
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
May 5, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045149
Brief Title
Biological Therapy in Treating Patients With Metastatic Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
therapeutic tumor infiltrating lymphocytes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassian Yee, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

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Biological Therapy in Treating Patients With Metastatic Melanoma

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