ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

This study has been completed.
Study NCT00019214.   Last updated on October 18, 2008.   Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
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
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.

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 Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Melanoma (Skin)
Intervention  Drug: MART-1 antigen
Drug: aldesleukin
Drug: gp100 antigen
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  April 1997
Completion Date
Eligibility 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00019214
Organization ID CDR0000065234
Secondary IDs †† NCI-97-C-0046, NCI-97-C-0019, NCI-T96-0046N
Study Sponsor  NCI - Center for Cancer Research-Medical Oncology
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     James C. Yang, MD     NCI - Surgery Branch    
Information Provided By National Cancer Institute (NCI)
Verification Date January 2005
First Received Date  July 11, 2001
Last Updated Date October 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers