Suspended

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

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What is being tested

autologous dendritic cell-tumor fusion vaccine

+ gp100 antigen

+ therapeutic autologous dendritic cells

Biological
Who is being recruted

Melanoma+8

+ Neoplasms

+ Neoplasms by Histologic Type

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorDana-Farber Cancer Institute
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00085397
Principal SponsorDana-Farber Cancer Institute
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

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

Boston, United StatesSee the location
Recruiting

Beth Israel Deaconess Medical Center

Boston, United States
Recruiting

Massachusetts General Hospital

Boston, United States
Suspended3 Study Centers