NCT00004104

Brief Summary

RATIONALE: Vaccines may make the body build an immune response and kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Interferon alfa-2b may interfere with the growth of tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of vaccine therapy plus interleukin-2 with or without interferon alfa-2b in treating patients who have stage III melanoma.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2000

Completed
4.1 years until next milestone

First Posted

Study publicly available on registry

July 19, 2004

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

2.1 years

First QC Date

December 10, 1999

Last Update Submit

March 30, 2016

Conditions

Melanoma (Skin)

Keywords

stage III melanoma

Interventions

liposomal interleukin-2BIOLOGICAL
polyvalent melanoma vaccineBIOLOGICAL
recombinant interferon alfaBIOLOGICAL

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven, surgically resected stage III melanoma Clinically positive nodes AND/OR At least 2 histologically positive nodes HLA-A2, A3, A11, or A26 positive Intact cellular immunity as evidenced by at least 5 mm reaction at 48 hours to at least 1 of the following recall antigens: PPD Mumps Candida Streptokinase streptodornase OR able to be sensitized to dinitrochlorobenzene PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: ECOG 0-2 Life expectancy: At least 12 months Hematopoietic: WBC greater than 3500/mm3 Platelet count greater than 100,000/mm3 Hematocrit greater than 30% Hepatic: Bilirubin less than 2.0 mg/dL SGOT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN Prothrombin time normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No significant cardiovascular disease No uncontrolled hypertension No congestive heart failure No uncontrolled cardiac arrhythmia No active angina pectoris No myocardial infarction in the past 12 months Pulmonary: Other: No second malignancy except carcinoma in situ of the cervix or basal or squamous cell skin cancer No autoimmune disease HIV negative No significant medical illness that would preclude compliance At least 4 weeks since prior serious infection requiring antibiotics Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior melanoma vaccine No prior immunotherapy No other concurrent immunotherapy Chemotherapy: No prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior glucocorticosteroids for nonmalignant purposes No concurrent steroids Radiotherapy: No concurrent radiotherapy Surgery: At least 4 weeks (but no more than 12 weeks) since prior major surgery 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)

Kaplan Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

CanvaxinInterferon-alpha

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)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Jean-Claude Bystryn, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 10, 1999

First Posted

July 19, 2004

Study Start

June 1, 1998

Primary Completion

July 1, 2000

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

US(1)