NCT00022568

Brief Summary

RATIONALE: Vaccines 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

August 1, 2001

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2003

First QC Date

August 10, 2001

Last Update Submit

December 17, 2013

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Interventions

recombinant vaccinia-TRICOM vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph node malignant melanoma * Lesion(s) must be accessible to percutaneous injection * Measurable lesion(s) * At least 1.0 cm * Previously treated brain metastases with no evidence of disease or edema on MRI or CT scan allowed * At least 6 weeks since prior definitive therapy (surgery or radiotherapy) * No untreated or edematous metastatic brain lesions or leptomeningeal disease * No ascites or pleural effusions PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-1 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 3,000/mm3 * Platelet count at least 100,000/mm3 * Absolute granulocyte count at least 3,000/mm3 * Hemoglobin at least 10 g/dL Hepatic: * Direct bilirubin no greater than 1.5 mg/dL * Transaminases no greater than 2 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN * No severe coagulation disorder with PT/PTT greater than 2 times normal (without anticoagulation medications) * No hepatic insufficiency * No alcoholic cirrhosis Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 60 mL/min * No renal insufficiency Cardiovascular: * No congestive heart failure * No serious cardiac arrhythmias * No evidence of recent prior myocardial infarction on EKG * No clinical coronary artery disease Pulmonary: * No chronic obstructive pulmonary disease Immunologic: * No prior eczema * HIV negative * No immunocompromising conditions, (e.g., active autoimmune disease, leukemia, lymphoma, skin diseases, or open wounds) * No clinical or laboratory evidence of an underlying immunosuppressive disorder * No active or chronic infections * No significant allergy or hypersensitivity to eggs Other: * No active seizure disorders * No other malignancy within the past 2 years except stage I cervical cancer or basal cell skin cancer, provided the tumor has been successfully treated and patient is currently disease free * No evidence of bone marrow toxicity * No other concurrent medical illness that would preclude study * No other contraindications to vaccinia virus administration * No encephalitis * Must be able to avoid close contact with children under 3 years of age; pregnant women; individuals with prior or active eczema or other open skin conditions; or immunosuppressed individuals for 7-10 days after each vaccination * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior vaccinia immunization required (e.g., smallpox vaccination) * More than 8 weeks since prior immunotherapy and recovered * No prior therapy with live vaccinia virus vector Chemotherapy: * More than 4 weeks since prior chemotherapy and recovered Endocrine therapy: * At least 4 weeks since prior systemic corticosteroids * No concurrent systemic corticosteroids * No concurrent steroids Radiotherapy: * See Disease Characteristics * More than 2 weeks since prior radiotherapy and recovered Surgery: * See Disease Characteristics * More than 4 weeks since prior surgery for primary tumor or metastatic lesions and recovered Other: * No concurrent immunosuppressive drugs

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

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

rV-Tricom

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

  • Howard L. Kaufman, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

August 1, 2001

Last Updated

December 18, 2013

Record last verified: 2003-12

Locations

US(1)