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B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

B7-DC Xab Plasma Therapy for the Treatment of Metastatic Melanoma. A Feasibility/Pilot Study


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of B7-dendritic cell cross-linking antibody

Safety Issue:

Yes

Principal Investigator

Svetomir Markovic, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000593085

NCT ID:

NCT00658892

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • Melanoma

Name

Location

Mayo ClinicRochester, Minnesota  55905