Vaccine Therapy in Treating Patients With Metastatic Melanoma

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Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

filgrastim

therapeutic autologous dendritic cells

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma HLA-A2-01 phenotype Measurable disease No active CNS or hepatic metastases PATIENT CHARACTERISTICS: Age: 21 and over Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics No viral hepatitis Renal: Not specified Cardiovascular: No prior venous thrombosis, angina pectoris, or congestive heart failure Lactate dehydrogenase less than 2 times normal Pulmonary: No prior asthma Immunologic: Intradermal skin test positivity to mumps, Candida, or streptokinase antigen No known sensitivity to E. coli drug preparations No prior allergy to influenza vaccine No active infection No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis) Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 8 weeks since prior interleukin-2 At least 4 weeks since prior interferon alfa Chemotherapy: At least 8 weeks since prior chemotherapy Endocrine therapy: At least 2 weeks since prior corticosteroids No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent immunosuppressive agents At least 2 weeks since prior immunosuppressive agents

Sites / Locations

Baylor University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00017355

First Posted

June 6, 2001

Last Updated

September 16, 2013

Sponsor

Baylor Health Care System

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00017355

Brief Title

Vaccine Therapy in Treating Patients With Metastatic Melanoma

Official Title

Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2003

Overall Recruitment Status

Unknown status

Study Start Date

April 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Baylor Health Care System

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

Detailed Description

OBJECTIVES: Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma. Determine the longevity of melanoma-specific immunity in patients treated with this regimen. Perform serial analysis of T-cell and B-cell function in patients treated with this regimen. OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or 1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35, gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation. Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression. Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years. PROJECTED ACCRUAL: A total of 18 patients 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

stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Biological

Intervention Name(s)

therapeutic autologous dendritic cells

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma HLA-A2-01 phenotype Measurable disease No active CNS or hepatic metastases PATIENT CHARACTERISTICS: Age: 21 and over Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: See Disease Characteristics No viral hepatitis Renal: Not specified Cardiovascular: No prior venous thrombosis, angina pectoris, or congestive heart failure Lactate dehydrogenase less than 2 times normal Pulmonary: No prior asthma Immunologic: Intradermal skin test positivity to mumps, Candida, or streptokinase antigen No known sensitivity to E. coli drug preparations No prior allergy to influenza vaccine No active infection No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis) Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 8 weeks since prior interleukin-2 At least 4 weeks since prior interferon alfa Chemotherapy: At least 8 weeks since prior chemotherapy Endocrine therapy: At least 2 weeks since prior corticosteroids No concurrent corticosteroids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent immunosuppressive agents At least 2 weeks since prior immunosuppressive agents

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph W. Fay, MD

Organizational Affiliation

Baylor Health Care System

Official's Role

Study Chair

Facility Information:

Facility Name

Baylor University Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Melanoma (Skin)

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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