Recruiting
Phase 2

Vaccine Therapy & gp100

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT00085397

Conditions

Melanoma (Skin)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

autologous dendritic cell-tumor fusion vaccine

gp100 antigen

therapeutic autologous dendritic cells

Study Details

Brief summary:

RATIONALE: Vaccines made from a patient's dendritic cells may make the body build an immune response to kill tumor cells. It is not yet known whether combining vaccine therapy with either gp100 antigen or the patient's tumor cells will cause a stronger immune response and kill more tumor cells.

PURPOSE: This randomized phase II trial is studying vaccine therapy and gp100 antigen to see how well they work compared to vaccine therapy and patient's tumor cells in treating patients with stage III or stage IV melanoma.

Conditions

Melanoma (Skin)

Study ID

NCT00085397

Start date

Mar, 2004

Status verified date

Apr, 2008

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I

Patients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising dendritic cells (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.

experimental: 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.

Interventions

autologous dendritic cell-tumor fusion vaccine

Given subcutaneously

gp100 antigen

Given IV

therapeutic autologous dendritic cells

Given IV

Primary outcome measure

  • Immune response [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Clinical Trials Office - Massachusetts General Hospital

877-726-5130

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

F. Stephen Hodi, MD

617-632-5053

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Clinical Trials Office - Beth Israel Deaconess Medical Center

617-667-9925

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Feb 9, 2009

Last verified

Apr, 2008

Keywords

  • recurrent melanoma
  • stage III melanoma
  • stage IV melanoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2009-02-09.