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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00019214
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: MART-1 antigen Biological: aldesleukin Biological: gp100 antigen Phase 1 Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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
Study Start Date : April 1997
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma Vaccines

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019214


Locations
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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Study Chair: James C. Yang, MD NCI - Surgery Branch
More Information
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ClinicalTrials.gov Identifier: NCT00019214    
Obsolete Identifiers: NCT00001558
Other Study ID Numbers: CDR0000065234
NCI-97-C-0046
NCI-97-C-0019
NCI-T96-0046N
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: January 2005
Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Aldesleukin
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents