NCT00003568

Brief Summary

RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with interleukin-2 in treating patients with metastatic melanoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 1998

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

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

Study Start

First participant enrolled

November 1, 1998

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

June 26, 2013

Status Verified

November 1, 2005

First QC Date

November 1, 1999

Last Update Submit

June 25, 2013

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Interventions

aldesleukinBIOLOGICAL
gp100 antigenBIOLOGICAL
incomplete Freund's adjuvantBIOLOGICAL

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed clearly progressive metastatic or unresectable melanoma * Must be HLA-A2.1 positive * Measurable disease * No active brain metastases, leptomeningeal disease, or seizure disorder * More than 4 months since prior definitive therapy (surgery or radiotherapy) for brain metastases and must not have evidence of disease on brain CT scan or MRI * No ascites or pleural effusions PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 OR * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No congestive heart failure * No symptoms of coronary artery disease * No serious cardiac arrhythmias * No evidence of prior myocardial infarction on EKG * Normal cardiac stress test required for all patients over 40 years Pulmonary: * FEV\_1 greater than 2.0 liters or at least 75% of predicted * No chronic obstructive pulmonary disease Other: * HIV negative * No significant systemic infection * No contraindication to use of pressor agents * No history of major psychiatric illness * No other major illness that would significantly increase the risk of immunotherapy * No other active malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ or stage I carcinoma of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior interleukin-2 * At least 4 weeks since prior vaccine therapy or other cytokine therapy Chemotherapy: * One prior chemotherapy regimen allowed * At least 4 weeks since prior chemotherapy (6 weeks for carmustine or lomustine) and recovered Endocrine therapy: * No concurrent steroids Radiotherapy: * See Disease Characteristics * No prior radiotherapy to areas of measurable disease unless there has been clearly progressive disease in this site or there is measurable disease outside of areas of prior radiation * At least 2 weeks since prior radiotherapy for local control or palliative therapy and recovered Surgery: * See Disease Characteristics * Recovered from prior major surgery * No prior organ allografts Other: * No antihypertensive therapy within 24 hours prior to interleukin-2

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

Sponsors & Collaborators

Study Sites (9)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-0269, United States

Location

University of Illinois at Chicago Health Sciences Center

Chicago, Illinois, 60612, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Comprehensive Cancer Center at Our Lady of Mercy Medical CenterOur

The Bronx, New York, 10466, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15236, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2516, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukinincomplete Freund's adjuvant

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

  • David M. Gustin, MD

    University of Illinois at Chicago

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

November 1, 1998

Study Completion

December 1, 2005

Last Updated

June 26, 2013

Record last verified: 2005-11

Locations

US(9)