Biological Therapy in Treating Patients With Metastatic Melanoma - Full Text View

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00002786

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 I Phase II

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:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Aldesleukin

U.S. FDA Resources

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Cassian Yee, MD

Fred Hutchinson Cancer Research Center

More Information

Additional Information:

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

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 February 12, 2012