NCT00045149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2002

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2002

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2002

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 28, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

May 7, 2010

Status Verified

May 1, 2010

First QC Date

September 6, 2002

Last Update Submit

May 5, 2010

Conditions

Melanoma (Skin)

Keywords

recurrent melanomastage IV melanoma

Interventions

aldesleukinBIOLOGICAL
therapeutic tumor infiltrating lymphocytesBIOLOGICAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Cassian Yee, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2002

First Posted

May 28, 2003

Study Start

October 1, 2002

Study Completion

June 1, 2005

Last Updated

May 7, 2010

Record last verified: 2010-05

Locations

US(1)