Full Text View
Tabular View
No Study Results Posted
Related Studies
Adesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: July 11, 2001   Last Updated: June 9, 2009   History of Changes
Sponsors and Collaborators: Goshen Health System
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: Treatment, Randomized, Active Control
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 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
Estimated Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Active Comparator
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
Arm II: Experimental
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 Recruiting
Birmingham, Alabama, United States, 35294
Contact: Clinical Trials Office - Lurleen Wallace Comprehensive Cancer     205-934-0309        
United States, Arizona
Mayo Clinic Hospital Recruiting
Phoenix, Arizona, United States, 85054-4502
Contact: Barbara A. Pockaj, MD     480-301-6551     pockaj.barbara@mayo.edu    
United States, California
Kaiser Permanente Medical Center - Riverside Recruiting
Riverside, California, United States, 92505-3000
Contact: Fawaz Gailani, MD, FACP     951-353-4558        
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center     720-848-0650        
United States, Florida
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Recruiting
Lakeland, Florida, United States, 33804-1057
Contact: Douglas S. Reintgen, MD     863-603-6565        
United States, Illinois
Advocate Lutheran General Cancer Care Center Recruiting
Park Ridge, Illinois, United States, 60068-1174
Contact: Clinical Trials Office - Advocate Lutheran General Cancer Care     847-384-3621        
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
United States, Indiana
Center for Cancer Care at Goshen General Hospital Recruiting
Goshen, Indiana, United States, 46526
Contact: Clinical Trials Office - Center for Cancer Care at Goshen Gene     574-535-2858        
United States, Kentucky
James Graham Brown Cancer Center at University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Donald M. Miller, MD, PhD     502-562-4790     donaldmi@ulh.org    
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28232-2861
Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas     704-355-2884        
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service     866-627-7616     osu@emergingmed.com    
Christ Hospital Cancer Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Philip D. Leming, MD     513-585-0844     pianoblues@aol.com    
United States, Pennsylvania
St. Luke's Cancer Network at St. Luke's Hospital Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Lee B. Riley, MD, PhD, FACS     610-954-2310        
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
United States, Wisconsin
Medical Consultants, Limited Recruiting
Milwaukee, Wisconsin, United States, 53215-3690
Contact: Jonathan S. Treisman, MD     414-385-3086        
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

No publications provided

Responsible Party: Center for Cancer Care at Goshen General Hospital ( Douglas Jay Schwartzentruber )
Study ID Numbers: CDR0000066963, CCCGHS-NCI-T98-0085, NCI-T98-0085, NCI-99-C-0051B
Study First Received: July 11, 2001
Last Updated: June 9, 2009
ClinicalTrials.gov Identifier: NCT00019682     History of Changes
Health Authority: Unspecified

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

Study placed in the following topic categories:
Anti-HIV Agents
Immunologic Factors
Adjuvants, Immunologic
Antiviral Agents
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
 Aldesleukin
Anti-Retroviral Agents
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Freund's Adjuvant
Nevus

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

ClinicalTrials.gov processed this record on July 02, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services