Conditions

Melanoma (Skin)

Keywords

stage III melanomastage IV melanomarecurrent melanoma

Outcome Measures

Primary Outcomes (1)

Compare AEs and SAES in subjects receiving 4B5 plus adjuvant sargramostim (GM-CSF) to alum in patients with stage III or IV melanoma at high risk for recurrence following surgical resection.
Baseline to last dose of study drug

Secondary Outcomes (3)

Compare the development of humoral and/or cellular anti-idiotypic immune response between arm I and arm II
baseline to last dose of study drug
Compare if the immune response generated against 4B5 is also directed against the melanoma-associated GD2 antigen between Arm I and Arm II
baseline through last dose of study drug
Measure the immune response to GD2 between subjects receiving the 4B5 plus adjuvant GM-CSF to subjects receiving 4B5 plus alum
baseline to survival

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive human anti-idiotypic monoclonal antibody vaccine (4B5) in sargramostim (GM-CSF) subcutaneously (SQ) on days 0, 14, 28, and 42. Patients receive GM-CSF alone SQ at vaccination site on days 2, 3, and 4 following immunization.

Biological: monoclonal antibody 4B5 anti-idiotype vaccineBiological: sargramostim

Arm II

EXPERIMENTAL

Patients receive 4B5 plus alum SQ on days 0, 14, 28, and 42. Cohorts of 5 patients receive treatment every 2 weeks for up to 4 courses in the absence of unacceptable toxicity.

Biological: monoclonal antibody 4B5 anti-idiotype vaccineDrug: alum adjuvant

Interventions

monoclonal antibody 4B5 anti-idiotype vaccineBiological

Arm IArm II

sargramostimBiological

Arm I

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Pathologically proven stage III or IV melanoma at high risk for recurrence following surgical resection The following patients are eligible: Resected satellite or intransit metastasis with no evidence of residual disease OR Resected solitary metastatic lesion(s) with no residual disease OR Metastatic melanoma with measurable disease without noncutaneous lesion(s) greater than 5 cm in diameter OR Stage III disease not eligible for interferon alfa therapy No active CNS disease PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: BUN less than 30 mg/dL Creatinine less than 2 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception HIV negative No prior or concurrent active peripheral neuropathy No immunodeficiency disorder or immunodeficiency state No other prior or concurrent malignancy, except: Curatively treated basal or squamous cell skin cancer Carcinoma in situ of the cervix No hypersensitivity to GM-CSF, yeast derived products, or any study component PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent immunotherapy Chemotherapy: At least 6 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen as adjuvant or for metastatic disease No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior glucocorticoids No concurrent systemic corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since other prior investigational drugs No concurrent immunosuppressive therapy (e.g., cimetidine) No concurrent chronic antihistamine therapy

Sponsors & Collaborators

University of Alabama at Birmingham
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

MeSH Terms

Conditions

Melanoma

Interventions

sargramostimAluminum Hydroxide

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

Donald M. Miller, MD, PhD
James Graham Brown Cancer Center at University of Louisville
STUDY CHAIR

Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Arm I

Arm II

Interventions

Eligibility Criteria

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Arm I

Arm II

Interventions

Eligibility Criteria

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record