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Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

Primary Purpose

Melanoma (Skin)

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
autologous dendritic cell-tumor fusion vaccine
gp100 antigen
therapeutic autologous dendritic cells
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage III melanoma, stage IV melanoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Immune response

Secondary Outcome Measures

Full Information

First Posted
June 10, 2004
Last Updated
February 6, 2009
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00085397
Brief Title
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage III melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
autologous dendritic cell-tumor fusion vaccine
Intervention Description
Given subcutaneously
Intervention Type
Biological
Intervention Name(s)
gp100 antigen
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous dendritic cells
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Immune response

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Haluska, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Avigan, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Massachusetts General Hospital
Phone
877-726-5130
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
F. Stephen Hodi, MD
Phone
617-632-5053
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Beth Israel Deaconess Medical Center
Phone
617-667-9925

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

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