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

This study has been completed.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019175
  Purpose

RATIONALE: Vaccines made from an antigen combined with a modified virus may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy with interleukin-2 may kill more tumor cells.

PURPOSE: Phase I trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have recurrent metastatic melanoma that has not responded to previous therapy.


Condition Intervention Phase
Melanoma (Skin)
Drug: aldesleukin
Drug: fowlpox virus vaccine vector
Drug: gp100 antigen
Phase I

MedlinePlus related topics:   Cancer    Melanoma   

Drug Information available for:   Aldesleukin    Interleukin-2   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   PHASE I TRIAL IN PATIENTS WITH METASTATIC MELANOMA OF IMMUNIZATION WITH A RECOMBINANT FOWLPOX VIRUS ENCODING THE GP100 MELANOMA ANTIGEN

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 1996

Detailed Description:

OBJECTIVES: I. Evaluate the toxicity, immunologic reactivity, and possible therapeutic efficacy of immunization with recombinant fowlpox virus encoding the gp100 melanoma antigen administered alone or with interleukin-2 in patients with metastatic melanoma.

OUTLINE: This is a dose-escalation study. Patients receive recombinant fowlpox virus encoding the gp100 melanoma antigen (FPV-gp100) IV or intramuscularly to rotating sites or fowlpox virus encoding modified gp100 melanoma antigen IV every 2 weeks for 4 vaccinations. Treatment continues for a maximum of 2 courses in the absence of disease progression. Cohorts of 3-9 patients receive escalating doses of FPV-gp100 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity. Patients in 3 of 5 cohorts also receive interleukin-2 (IL-2) within 12 hours of FPV-gp100. One cohort receives IL-2 subcutaneously daily on days 1-5 and days 8-12. A second cohort receives low-dose IL-2 IV over 15 minutes every 8 hours on days 2-8. A third cohort receives high-dose IL-2 IV over 15 minutes every 8 hours on days 2-6. Patients in cohorts 4 and 5 receive FPV-gp100 alone and, if no response is observed after 2 courses, may receive 2 courses of IL-2 alone every 8 hours for 5 days, approximately 2 weeks apart. A separate cohort of 3-9 patients receives modified FPV-gp100. If no response is observed after 2 courses, IL-2 may be administered as in cohorts 4 and 5. Patients are followed at 28 days after the second immunization with FPV-gp100.

PROJECTED ACCRUAL: A maximum of 91 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma that has failed standard therapy Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 8.0 g/dL No coagulation disorder Hepatic: Bilirubin no greater than 2.0 mg/dL AST and ALT less than 4 times normal Hepatitis B negative Renal: Creatinine no greater than 1.6 mg/dL Cardiovascular: No major cardiovascular disease Pulmonary: No major respiratory disease Other: HIV negative No other major immunologic illness No eczema No hypersensitivity to eggs No active systemic infection No psoriasis Not pregnant Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 20 days since prior therapy No concurrent steroid therapy

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019175

Locations
United States, Maryland
Surgery Branch    
      Bethesda, Maryland, United States, 20892

Sponsors and Collaborators
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Study Chair:     Steven A. Rosenberg, MD, PhD     NCI - Surgery Branch    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000064960, NCI-96-C-0121, NCI-T94-0139N
First Received:   July 11, 2001
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00019175
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma  
recurrent melanoma  

Study placed in the following topic categories:
Virus Diseases
Neuroectodermal Tumors
Aldesleukin
Interleukin-2
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms
Anti-HIV Agents
Neoplasms by Histologic Type
Anti-Retroviral Agents
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008




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