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PHASE III TRIAL OF MELACINE PLUS INTERFERON ALFA-2B VERSUS INTERFERON ALFA-2B IN PATIENTS WITH DISSEMINATED MALIGNANT MELANOMA


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

Thank you

Trial Information

PHASE III TRIAL OF MELACINE PLUS INTERFERON ALFA-2B VERSUS INTERFERON ALFA-2B IN PATIENTS WITH DISSEMINATED MALIGNANT MELANOMA


OBJECTIVES: I. Compare survival following immunotherapy with an allogeneic melanoma vaccine
plus interferon alfa-2b (IFN-A) vs. IFN-A alone in patients with metastatic melanoma. II.
Assess the safety and toxicity of immunotherapy with an allogeneic melanoma vaccine plus
IFN-A in these patients. III. Compare the frequencies of durable complete responses in each
treatment group. IV. Compare overall clinical objective response, duration of response, and
time to disease progression in each treatment group. V. Compare the effects of immunotherapy
with an allogeneic melanoma vaccine plus IFN-A vs IFN-A alone on quality of life in these
patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by location of
metastatic sites (visceral and bone vs nonvisceral and lung) and number of metastatic sites
(1 vs 2 vs 3 or more). Patients are randomized to one of two treatment arms. Arm I: Patients
receive allogenic melanoma cell lysate vaccine with detoxified endotoxin subcutaneously (SQ)
weekly on weeks 1-5 and 8-12. Interferon alfa (IFN-A) SQ is administered three times a week
beginning on week 4. Patients with responding or stable disease receive vaccine monthly
beginning on week 16. IFN-A continues in the absence of disease progression or unacceptable
toxicity. Arm II: Patients receive IFN-A SQ three times a week beginning on week 1.
Treatment continues in the absence of disease progression or unacceptable toxicity. Quality
of life is assessed before, during, and after treatment. Patients are followed every 3
months.

PROJECTED ACCRUAL: Approximately 300 patients will be entered over 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma that is metastatic
(any pT, any N, M1 by AJCC staging) Measurable disease by physical exam or noninvasive
radiologic procedure No concurrent or prior diagnosis of ocular melanoma No CNS metastases
No patients who can be rendered NED by surgery unless patient declines surgery

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy:
At least 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet
count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no
greater than 3 times normal No evidence of hepatic failure No active hepatitis Renal:
Creatinine clearance at least 40 mL/min Cardiovascular: No myocardial infarction within 6
months No decompensating congestive heart failure No unstable angina No current
symptomatic arrhythmia Other: No known HIV antibody No thyroid abnormality uncontrollable
by medication No medical, sociological, or psychological impediment to study compliance No
pre-existing psychiatric condition (especially depression) or history of severe
psychiatric disorder No autoimmune disease (e.g., systemic lupus erythematosus, multiple
sclerosis, ankylosing spondylitis) No concurrent malignancy except nonmelanomatous skin
cancer Not pregnant or nursing Negative pregnancy test Effective contraception required of
fertile women No history of egg allergies

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 12 months since interferon alfa or
melanoma vaccine No prior immunotherapy for metastatic disease No concurrent cytokines or
levamisole Chemotherapy: No prior chemotherapy for metastatic disease At least 4 months
since adjuvant therapy No concurrent chemotherapy Endocrine therapy: At least 1 week since
corticosteroids No concurrent immunosuppressives (e.g., azathioprine or cyclosporine)
Radiotherapy: Prior radiotherapy for metastatic disease allowed Surgery: See Disease
Characteristics Prior surgery for metastatic disease allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Kenneth B. Von Eschen, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Federal Government

Study ID:

CDR0000064732

NCT ID:

NCT00002767

Start Date:

January 1996

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Beckman Research Institute, City of HopeLos Angeles, California  91010
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Christ HospitalCincinnati, Ohio  45219
CCOP - ColumbusColumbus, Ohio  43206
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Kaiser Permanente Medical Center - VallejoVallejo, California  94589
University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
University of Connecticut Health CenterFarmington, Connecticut  06360-7106
Creighton University Cancer CenterOmaha, Nebraska  68131-2197
Southwest Regional Cancer CenterAustin, Texas  78705
Hematology Oncology Consultants IncColumbus, Ohio  43235
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
University of California San Diego Cancer Center - La JollaLa Jolla, California  92093-0686
Kaiser Permanente Medical Center-SacramentoSacramento, California  95825
Kaiser Permanente Medical Group - San FranciscoSan Francisco, California  94115
Adventist Health System/Sunbelt, Inc.Orlando, Florida  32803
Emory University School of MedicineAtlanta, Georgia  30322
University of Louisville HospitalLouisville, Kentucky  40202
Interlakes Oncology/Hematology PCRochester, New York  14623