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Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
This study has been completed.
Study NCT00019669   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
October 1999
 
 
 
Complete list of historical versions of study NCT00019669 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma.

PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment.

OBJECTIVES:

  • Compare the clinical response in patients with metastatic melanoma treated with immunization with recombinant fowlpox vaccine administered either intravenously or intramuscularly, with or without interleukin-2 (IL-2).
  • Compare the immune response in patients before and after treatment with these regimens.
  • Compare the toxicity profile of these regimens in these patients.

OUTLINE: This is a partially randomized study. Patients are randomized to 1 of 3 treatment cohorts.

  • Cohort 1: Patients receive recombinant fowlpox virus encoding gp100 peptide (fowlpox vaccine) IV once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/02.)
  • Cohort 2: Patients receive fowlpox vaccine intramuscularly (IM) once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/04.)
  • Cohort 3 (for patients in need of immediate interleukin-2 [IL-2] and those with disease progression after treatment in cohorts 1 or 2): Patients receive fowlpox vaccine either IV or IM* once every 4 weeks for 4 doses and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine.

NOTE: *The IM route of administration was selected as the preferred route of administration from cohorts 1 and 2

  • Expanded cohort 2 (open to accrual 7/19/02): Patients receive fowlpox vaccine IM once every 4 weeks for up to 4 doses. Upon disease progression, patients receive fowlpox vaccine as above and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine. (Closed to accrual 12/4/03.) In all cohorts, 3-4 weeks after the last injection, patients achieving a complete remission may receive a maximum of an additional 2 courses of therapy. Patients with responding disease may receive repeat vaccinations for up to 8 courses. Patients with no response or progressive disease in cohorts not receiving IL-2 may be treated with fowlpox vaccine and IL-2 as in cohort 3. Patients who are randomized to receive IL-2 may not receive additional IL-2 therapy.

PROJECTED ACCRUAL: A maximum of 84 patients (24 in cohorts 1 and 2, 19-33 in cohort 3, and 27 in expanded cohort 2) will be accrued for this study within 1 year.

Phase II
Interventional
Treatment, Open Label
Melanoma (Skin)
  • Biological: aldesleukin
  • Biological: fowlpox virus vaccine vector
  • Biological: gp100 antigen
 
Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Topalian SL, Sherry RM, Restifo NP, Wunderlich JR, Seipp CA, Rogers-Freezer L, Morton KE, Mavroukakis SA, Gritz L, Panicali DL, White DE. Recombinant fowlpox viruses encoding the anchor-modified gp100 melanoma antigen can generate antitumor immune responses in patients with metastatic melanoma. Clin Cancer Res. 2003 Aug 1;9(8):2973-80.

*   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 proven metastatic melanoma that has failed standard treatment
  • Measurable disease
  • HLA-A-201 positive

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 90,000/mm^3
  • No coagulation disorders

Hepatic:

  • Bilirubin ≤ 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
  • AST/ALT < 2 times normal
  • Hepatitis B surface antigen negative

Renal:

  • Creatinine ≤ 2.0 mg/dL

Cardiovascular:

  • No major cardiovascular disease
  • No cardiac ischemia by a stress thallium test or other comparable test*
  • No myocardial infarction*
  • No cardiac arrhythmias* NOTE: *In order to be eligible to receive interleukin-2 (IL-2)

Pulmonary:

  • No major respiratory disease
  • No obstructive or restrictive pulmonary disease* NOTE: *In order to be eligible to receive IL-2

Immunologic:

  • No autoimmune disease
  • No known immunodeficiency disease
  • No primary or secondary immunodeficiency
  • No allergy to eggs
  • No active systemic infections
  • HIV negative

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other active major medical illness* NOTE: *In order to be eligible to receive IL-2

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior gp100 vaccination

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No concurrent steroids

Radiotherapy:

  • Not specified

Surgery:

  • Prior surgery for the malignancy allowed

Other:

  • At least 3 weeks since other prior therapy for the malignancy
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00019669
 
CDR0000066961, NCI-99-C-0044, NCI-T98-0088
National Cancer Institute (NCI)
 
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
National Cancer Institute (NCI)
August 2004

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