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Adesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma
This study has been completed.

First Received on July 11, 2001.   Last Updated on October 11, 2011   History of Changes
Sponsor: Goshen Health System
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019682
  Purpose

RATIONALE: Aldesleukin may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating metastatic melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of aldesleukin with or without vaccine therapy in treating patients with stage III or stage IV melanoma.


Condition Intervention Phase
Melanoma (Skin)
 Biological: aldesleukin
Biological: gp100 antigen
Biological: incomplete Freund's adjuvant
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Multi-Institutional Randomized Study of Immunization With the GP100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients With Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Aldesleukin Montanide ISA 51 Freund's adjuvant
U.S. FDA Resources

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

Primary Outcome Measures:
  • Whether the addition of peptide vaccine to high-dose aldesleukin is superior to alaldesleukin alone by response rates after each course of treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity of treatment by NCI Common Toxicity Criteria after each course of treatment [ Designated as safety issue: Yes ]
  • Disease-free and progression-free survival comparison by disease evaluation every 3 months after treatment [ Designated as safety issue: No ]
  • Immunologic response to treatment by various laboratory studies before and after each course of treatment [ Designated as safety issue: No ]
  • Quality of life by Functional Assessment of Chronic Illness Therapy Fatigue Subscale RSF-36 SDS before and after the first course of treatment [ Designated as safety issue: No ]

Estimated Enrollment: 185
Study Start Date: June 2000
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive aldesleukin (IL-2) IV over 15 minutes every 8 hours for 12 doses. Treatment repeats every 3 weeks for 2 courses. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
 Biological: aldesleukin
Given IV
Experimental: Arm II
Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously on day 1. Patients also receive IL-2 as in arm I beginning on day 2. Treatment repeats every 3 weeks for 2 courses. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.
 Biological: aldesleukin
Given IV
Biological: gp100 antigen
Given subcutaneously
Biological: incomplete Freund's adjuvant
Given subcutaneously

Detailed Description:

OBJECTIVES:

  • Compare the efficacy of high-dose aldesleukin (IL-2) with or without gp100 antigen with regard to clinical response in patients with locally advanced or metastatic cutaneous melanoma.
  • Compare the toxic effects of these 2 regimens in these patients.
  • Compare the disease-free and progression-free survival of patients treated with these 2 regimens.
  • Determine the immunologic response experienced by patients who have received the peptide vaccination, as measured by changes in T-cell precursors from before to after treatment.
  • Evaluate the quality of life of these patients before and after the first course of high-dose IL-2.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease site (cutaneous or subcutaneous only vs any other site with or without subcutaneous disease).

Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive aldesleukin (IL-2) IV over 15 minutes every 8 hours for 12 doses.
  • Arm II: Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously on day 1. Patients also receive IL-2 as in arm I beginning on day 2.

In both arms, treatment repeats every 3 weeks for 2 courses. Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses. Patients with complete response may receive a maximum of 2 additional courses.

Quality of life is assessed before and after the first course of IL-2.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 93-185 patients (46-93 per treatment arm) will be accrued for this study within 2 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically proven locally advanced stage III or stage IV cutaneous melanoma

    • No ocular or mucosal melanoma
  • Measurable disease
  • HLA-A0201 positive
  • No brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Greater than 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 90,000/mm^3
  • No coagulation disorder

Hepatic:

  • Bilirubin no greater than 1.6 mg/dL
  • AST or ALT less than 3 times normal
  • No hepatitis B or C

Renal:

  • Creatinine no greater than 1.6 mg/dL

Cardiovascular:

  • No prior cardiac ischemia, myocardial infarction, or cardiac arrhythmias
  • Normal stress cardiac test (e.g., stress thallium or stress MUGA)

Pulmonary:

  • No prior obstructive or restrictive pulmonary disease
  • FEV_1 at least 65% OR
  • FVC at least 65%

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No active systemic infections
  • No autoimmune disease
  • No history of other major medical illnesses (e.g., insulin-dependent diabetes mellitus or inflammatory bowel disorder)
  • No significant psychiatric disease
  • No primary or secondary immunodeficiency

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy
  • No prior high-dose aldesleukin (600,000 IU/kg or more)
  • No prior gp100 vaccines
  • No other concurrent biologic therapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 4 weeks since prior systemic steroids
  • At least 2 weeks since prior topical or inhalational steroids
  • No concurrent steroid therapy or steroid-like compounds

Radiotherapy:

  • At least 4 weeks since prior radiotherapy to any site
  • No concurrent radiotherapy to any site

Surgery:

  • Prior surgery allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019682

Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054-4502
United States, California
Kaiser Permanente Medical Center - Riverside
Riverside, California, United States, 92505-3000
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Florida
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33804-1057
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
United States, Indiana
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526
United States, Kentucky
James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, United States, 40202
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
United States, Ohio
Christ Hospital Cancer Center
Cincinnati, Ohio, United States, 45219
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
United States, Wisconsin
Medical Consultants, Limited
Milwaukee, Wisconsin, United States, 53215-3690
Sponsors and Collaborators
Goshen Health System
National Cancer Institute (NCI)
Investigators
Study Chair: Douglas J. Schwartzentruber, MD Goshen Health System
Investigator: Daniel G. Bruetman, MD Goshen Health System
  More Information

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

Publications:
Schwartzentruber DJ, Lawson DH, Richards JM, Conry RM, Miller DM, Treisman J, Gailani F, Riley L, Conlon K, Pockaj B, Kendra KL, White RL, Gonzalez R, Kuzel TM, Curti B, Leming PD, Whitman ED, Balkissoon J, Reintgen DS, Kaufman H, Marincola FM, Merino MJ, Rosenberg SA, Choyke P, Vena D, Hwu P. gp100 peptide vaccine and interleukin-2 in patients with advanced melanoma. N Engl J Med. 2011 Jun 2;364(22):2119-27.

Responsible Party: Douglas Jay Schwartzentruber, Center for Cancer Care at Goshen General Hospital
ClinicalTrials.gov Identifier: NCT00019682     History of Changes
Obsolete Identifiers: NCT00001801
Other Study ID Numbers: CDR0000066963, CCCGHS-NCI-T98-0085, NCI-T98-0085, NCI-99-C-0051B
Study First Received: July 11, 2001
Last Updated: October 11, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Freund's Adjuvant
Aldesleukin
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 12, 2012



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