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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00004184
First received: January 21, 2000
Last updated: April 11, 2013
Last verified: March 2013

January 21, 2000
April 11, 2013
August 1998
June 2001   (final data collection date for primary outcome measure)
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. [ Time Frame: Baseline to last dose of study drug ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00004184 on ClinicalTrials.gov Archive Site
  • Compare the development of humoral and/or cellular anti-idiotypic immune response between arm I and arm II [ Time Frame: baseline to last dose of study drug ] [ Designated as safety issue: Yes ]
  • Compare if the immune response generated against 4B5 is also directed against the melanoma-associated GD2 antigen between Arm I and Arm II [ Time Frame: baseline through last dose of study drug ] [ Designated as safety issue: No ]
  • Measure the immune response to GD2 between subjects receiving the 4B5 plus adjuvant GM-CSF to subjects receiving 4B5 plus alum [ Time Frame: baseline to survival ] [ Designated as safety issue: No ]
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Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma
A Phase I/II Trial of a Human Anti-Idiotypic Monoclonal Antibody Vaccine (4B5) Which Mimics the GD2 Antigen, in Patients With Melanoma

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have stage III or stage IV melanoma at high risk for recurrence following surgery to remove the tumor.

OBJECTIVES: I. Determine the toxicity of the human anti-idiotypic monoclonal antibody vaccine (4B5) plus adjuvant sargramostim (GM-CSF) or alum in patients with stage III or IV melanoma at high risk for recurrence following surgical resection. II. Determine whether 4B5 is associated with the development of humoral and/or cellular anti-anti-idiotypic immune response in these patients. III. Determine whether the immune response generated against 4B5 is also directed against the melanoma-associated GD2 antigen in these patients. IV. Determine whether the 4B5 plus adjuvant GM-CSF or alum can elicit an immune response to GD2 in these patients.

OUTLINE: Patients are assigned sequentially to one of two treatment arms. Arm I: 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. Arm II: 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.

PROJECTED ACCRUAL: A maximum of 50 patients (25 per arm) will be accrued for this study.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: monoclonal antibody 4B5 anti-idiotype vaccine
  • Biological: sargramostim
  • Drug: alum adjuvant
  • Experimental: Arm I
    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.
    Interventions:
    • Biological: monoclonal antibody 4B5 anti-idiotype vaccine
    • Biological: sargramostim
  • Experimental: Arm II
    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.
    Interventions:
    • Biological: monoclonal antibody 4B5 anti-idiotype vaccine
    • Drug: alum adjuvant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2001
June 2001   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00004184
CDR0000067424, UAB-9746, UAB-F980729009, NCI-G99-1644
Yes
Not Provided
University of Alabama at Birmingham
National Cancer Institute (NCI)
Study Chair: Donald M. Miller, MD, PhD James Graham Brown Cancer Center at University of Louisville
University of Alabama at Birmingham
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP