Clinical trial NCT00658892: Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
Official title: B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma (Skin)
Keywords: recurrent melanoma
stage IV melanoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-04-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Monoclonal antibodies can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This clinical trial is studying the side effects and best dose of a monoclonal antibody in treating patients with stage IV melanoma.

Detailed description: OBJECTIVES:

Primary

* Determine the safety/toxicity of a single dose of B7-dendritic cell cross-linking antibody containing plasma in treating patients with stage IV melanoma.

Secondary

* Describe the immunological changes (Th1/Th2 balance, frequency of tumor specific cytotoxic T lymphocytes, and plasma cytokine profiles) in the treated patients.
* Determine the treatment impact on tumor growth (e.g., objective response, time to progression).

OUTLINE: Patients receive B7-dendritic cell cross-linking antibody IV once on day 1.

Patients undergo peripheral blood collection at baseline and periodically after infusion for analysis of dendritic cell activation, cytotoxic T-lymphocyte activity, immune cell impact, and serum cytokine changes using immunophenotyping and flow cytometry.

After completion of study treatment patients are followed every 2 months for 5 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed melanoma

  * Stage IV disease (M1a and M1b only)
* Measurable disease according to RECIST criteria
* HLA-A2 positive
* Must have IgA in serum (any concentration)
* No known standard therapy for this disease that is potentially curative or proven capable of extending life expectancy

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Hemoglobin ≥ 10.0 g/dL
* Platelet count ≥ 75,000/mm\^3
* AST ≤ 5 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to provide informed consent
* Agrees to return to Mayo Clinic Rochester for follow-up
* Agrees to participate in the mandatory translational research component of the study
* No uncontrolled or current infection
* No known immune deficiency
* No B or AB blood grouping

PRIOR CONCURRENT THERAPY:

* More than 4 weeks since prior chemotherapy and recovered
* More than 4 weeks since prior biologic therapy
* No concurrent immunosuppressive therapy

Primary outcomes:
measure: Maximum tolerated dose of B7-dendritic cell cross-linking antibody
Secondary outcomes:
measure: Progression free survival and overall survival time
measure: Toxicity
measure: Tumor response in terms of complete or partial response at 8 weeks
measure: Tetramer response
measure: Percent change in the number of T, B, NK cells, monocytes and dendritic cells from pretreatment levels as well as the percent change in plasma concentrations of various molecular components
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Svetomir Markovic, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: