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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 stage IV melanoma, recurrent melanoma

Eligibility Criteria

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

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
May 6, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002786
Brief Title
Biological Therapy in Treating Patients With Metastatic Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
October 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (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 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
20 (Anticipated)

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: 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
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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