Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Sponsored by: GlaxoSmithKline
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002767
  Purpose

RATIONALE: Interferon alfa may interfere with the growth of cancer cells.Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether melanoma vaccine plus interferon alfa is more effective than interferon alfa alone in treating patients with metastatic melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without vaccine therapy in treating patients with metastatic melanoma.


Condition Intervention Phase
Melanoma (Skin)
Drug: Detox-B adjuvant
Drug: recombinant interferon alfa
Phase III

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: PHASE III TRIAL OF MELACINE PLUS INTERFERON ALFA-2B VERSUS INTERFERON ALFA-2B IN PATIENTS WITH DISSEMINATED MALIGNANT MELANOMA

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

Estimated Enrollment: 300
Study Start Date: January 1996
Detailed Description:

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.

  Eligibility

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002767

  Show 27 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Chair: Kenneth B. Von Eschen, PhD GlaxoSmithKline
  More Information

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

Study ID Numbers: CDR0000064732, CORIXA-2885-14, RIR-2885-14, YALE-HIC-8666, NCI-V96-0883
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00002767  
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:
Interferon-alpha
Interferon Type I, Recombinant
Interferons
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Nevus
Interferon Alfa-2a
Interferon Alfa-2b

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Nevi and Melanomas
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 14, 2009