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A Randomized Phase II Study of Immunization Against Melanoma Comparing Autologous Dendritic Cells Pulsed With gp100 Peptide to Autologous Dendritic Cells Fused With Autologous Tumor Cells


Phase 2
N/A
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

A Randomized Phase II Study of Immunization Against Melanoma Comparing Autologous Dendritic Cells Pulsed With gp100 Peptide to Autologous Dendritic Cells Fused With Autologous Tumor Cells


OBJECTIVES:

Primary

- Compare the tumor-specific immune response, in terms of the number of gp100-specific
cytotoxic T-lymphocytes, T-cell production of interferon gamma, or T-cell proliferation
in response to in vitro exposure to gp100 and tumor lysate, in patients with stage III
or IV melanoma treated with autologous dendritic cells (DC) pulsed with gp100 antigen
vs autologous DC fused with autologous tumor cells.

Secondary

- Compare the safety and toxicity of these regimens in these patients.

- Compare the therapeutic effect of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

All patients undergo leukapheresis. Peripheral blood mononuclear cells are cultured to
generate dendritic cells (DC).

- Arm I: Patients undergo surgical harvesting of tumor cells for subsequent fusion.
Patients receive vaccination comprising DC fused with autologous tumor cells
subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who
achieve a partial (PR) or complete response (CR) may receive an additional 3 courses.

- Arm II: Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day
1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may
receive an additional 6 courses.

In both arms, patients are followed monthly for 6 months.

PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed cutaneous melanoma

- Stage III or IV disease

- Recurrent or de novo stage III disease allowed if disease is unresectable and no
definitive treatment is available

- gp100- and HLA-A201-positive

- Surgically accessible tumor, defined by 1 of the following:

- Pulmonary lesions approachable by thoracoscopic procedure

- Skin or superficial soft tissue or lymph node lesions amenable to resection
under local anesthesia

- Malignant ascites or pleural effusion

- Measurable disease in addition to surgically accessible tumor > 2.0 cm

- No CNS metastases

- No mucosal or ocular melanoma

PATIENT CHARACTERISTICS:

Age

- Any age

Performance status

- ECOG 0-1

Life expectancy

- More than 3 months

Hematopoietic

- WBC > 3,000/mm^3

- Platelet count > 75,000/mm^3

Hepatic

- Bilirubin < 2.0 mg/dL

Renal

- Creatinine < 2.0 mg/dL

Immunologic

- No active infection requiring treatment

- No clinically significant autoimmune disorder

- No immune deficiency disorder

- HIV negative

Other

- Antecubital vein accessible for leukapheresis

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
squamous cell carcinoma in situ of the cervix

- No pre-existing comorbid disease that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior melanoma vaccine therapy

- More than 6 weeks since prior immunotherapy

Chemotherapy

- No prior chemotherapy for metastatic melanoma

Endocrine therapy

- No concurrent corticosteroids

Radiotherapy

- More than 6 weeks since prior radiotherapy

Surgery

- Not specified

Other

- No concurrent systemic immunosuppressive therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Immune response

Safety Issue:

No

Principal Investigator

Frank Haluska, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

Unspecified

Study ID:

CDR0000369699

NCT ID:

NCT00085397

Start Date:

March 2004

Completion Date:

Related Keywords:

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

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617