NCT00017355

Brief Summary

RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 17, 2013

Status Verified

March 1, 2003

First QC Date

June 6, 2001

Last Update Submit

September 16, 2013

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Interventions

filgrastimBIOLOGICAL
therapeutic autologous dendritic cellsBIOLOGICAL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * HLA-A2-01 phenotype * Measurable disease * No active CNS or hepatic metastases PATIENT CHARACTERISTICS: Age: * 21 and over Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * See Disease Characteristics * No viral hepatitis Renal: * Not specified Cardiovascular: * No prior venous thrombosis, angina pectoris, or congestive heart failure * Lactate dehydrogenase less than 2 times normal Pulmonary: * No prior asthma Immunologic: * Intradermal skin test positivity to mumps, Candida, or streptokinase antigen * No known sensitivity to E. coli drug preparations * No prior allergy to influenza vaccine * No active infection * No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis) Other: * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 8 weeks since prior interleukin-2 * At least 4 weeks since prior interferon alfa Chemotherapy: * At least 8 weeks since prior chemotherapy Endocrine therapy: * At least 2 weeks since prior corticosteroids * No concurrent corticosteroids Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent immunosuppressive agents * At least 2 weeks since prior immunosuppressive 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)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Filgrastim

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Joseph W. Fay, MD

    Baylor Health Care System

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2001

First Posted

January 27, 2003

Study Start

April 1, 2001

Last Updated

September 17, 2013

Record last verified: 2003-03

Locations

US(1)