Expired Study
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Bethesda, Maryland 20892


RATIONALE: Vaccines made from white blood cells treated with antigens may make the body build an immune response to kill melanoma cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may kill more melanoma cells. PURPOSE: This phase I/II trial is studying the side effects and how well giving vaccine therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with metastatic melanoma that has not responded to previous therapy.

Study summary:

OBJECTIVES: - Evaluate the toxicity, immunologic reactivity, and possible therapeutic efficacy of immunization with dendritic cells presenting the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with metastatic melanoma. OUTLINE: This is a dose-escalation study of dendritic cells pulsed with MART-1 and gp100 antigens. Patients receive vaccinations with dendritic cells pulsed with MART-1 and gp100 antigens, either intralymphatically every 4 weeks for 2 doses, or IV every 3 weeks for 4 doses. Some patients also receive interleukin-2 subcutaneously or IV, over 3-5 days, beginning 24 hours after immunization. Cohorts of 2-9 patients receive escalating doses of pulsed dendritic cells IV until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Subsequent cohorts receive cells with or without interleukin-2. One cohort may expand to 15 patients to determine the accuracy of immunologic response to the vaccine. One cohort of 11 patients receives cells intralymphatically without interleukin-2 every 3-4 weeks for 2 courses. Patients with stable disease or who achieve minor, mixed, or partial response may be retreated. Patients with stable or responding disease undergo a second course of vaccination. Patients who completed treatment with vaccine alone and have stable disease, progressive disease, disease progression after a response, or a partial response with no further improvement may receive 2 additional courses. PROJECTED ACCRUAL: A total of 10-42 patients will be accrued for this study.


DISEASE CHARACTERISTICS: - Histologically confirmed metastatic melanoma that has failed standard effective therapy - Measurable or evaluable disease - HLA-A2 positive PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - More than 3 months Hematopoietic: - WBC greater than 3,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 8.0 g/dL Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST/ALT less than 4 times upper limit of normal - Negative hepatitis B surface antigen - No coagulation disorder Renal: - Creatinine no greater than 1.6 mg/dL OR - Creatinine clearance greater than 75 mL/min Cardiovascular: - No major cardiovascular disease Pulmonary: - No major respiratory disease Other: - No major immunological disease - No penicillin allergy - HIV negative - No active systemic infection - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - At least 4 weeks since prior steroid therapy and recovered Radiotherapy - Not specified Surgery - Not specified Other - More than 4 weeks since any other prior therapy and recovered

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

Official Title:

Phase I/II Study in Patients With Metastatic Melanoma of Immunization With Dendritic Cells Presenting Epitopes Derived From The Melanoma Associated Antigens MART-1 and gp 100

Overall Status:


Study Phase:

Phase 1/Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)

Oversight Authority:

United States: Federal Government

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:James C. Yang, MD
Study Chair
NCI - Surgery Branch

Study Dates

Start Date:April 1997
Completion Date:July 2006
Completion Type:Actual
Verification Date:January 2005
Last Changed Date:June 18, 2013
First Received Date:July 11, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:MART-1 antigen
Intervention Type:Biological
Intervention Type:Biological
Name:gp100 antigen

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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