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Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
This study has been completed.
Study NCT00019214   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 6, 2009   History of Changes

July 11, 2001
February 6, 2009
April 1997
 
 
 
Complete list of historical versions of study NCT00019214 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
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

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.

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.

Phase I, Phase II
Interventional
Treatment
Melanoma (Skin)
  • Biological: MART-1 antigen
  • Biological: aldesleukin
  • Biological: gp100 antigen
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00019214
 
CDR0000065234, NCI-97-C-0046, NCI-97-C-0019, NCI-T96-0046N
National Cancer Institute (NCI)
 
Study Chair: James C. Yang, MD NCI - Surgery Branch
National Cancer Institute (NCI)
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP