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Vaccine Therapy Compared With Interferon Alfa in Treating Patients With Stage III Melanoma

This study is ongoing, but not recruiting participants.

Sponsored by: AVAX Technologies
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003715
  Purpose

RATIONALE: Vaccines made from a person's melanoma cells may make the body build an immune response to kill tumor cells. Interferon alfa may interfere with the growth of the cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of melanoma vaccine with that of interferon alfa-2b in treating patients who have stage III melanoma that has spread to regional lymph nodes following surgery.


Condition Intervention Phase
Melanoma (Skin)
Drug: BCG vaccine
Drug: autologous tumor cell vaccine
Drug: cyclophosphamide
Drug: recombinant interferon alfa
Procedure: chemotherapy
Phase II

MedlinePlus related topics:   Cancer    Melanoma   

ChemIDplus related topics:   Cyclophosphamide    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons    BCG Vaccine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   A Prospective, Randomized, Open-Label, Comparative Clinical Trial in Post-Surgical Melanoma Patients With Either DNP-Modified Autologous Tumor Vaccine or Interferon Alpha-2b

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

Estimated Enrollment:   425
Study Start Date:   December 1998

Detailed Description:

OBJECTIVES: I. Compare the relapse-free and overall survival rates in patients with stage III melanoma treated with autologous tumor vaccine versus interferon alfa-2b as postsurgical adjuvant therapy. II. Compare the safety and tolerability of these regimens in this patient population.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to number of metastatic lymph node sites (1 vs more than 1), number of positive lymph nodes in a single site (none vs 1 or more), presence of intransit metastases (yes vs no), and evidence of extranodal extension (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive autologous tumor cell vaccine intradermally once a week for 7 weeks followed by a booster injection at 6 months. BCG is given concurrently with vaccine as an immune-stimulator for doses 2-8. Patients also receive cyclophosphamide 6 days after the first vaccine injection. Arm II: Patients receive interferon alfa-2b IV for 5 consecutive days a week for 4 weeks followed by maintenance doses given subcutaneously 3 times a week for 48 weeks. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 386-425 patients will be accrued for this study.

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

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed melanoma metastatic to regional lymph nodes with a clinically palpable mass Must have clinical evidence of the following: Metastases in 1 nodal site All other nodes microscopically negative No intransit metastases No extranodal extension OR Metastases in more than 1 nodal site More than 1 positive lymph node in a single site Intransit metastases Extranodal extension Must have undergone complete resection of tumor, measuring at least 2 cm in diameter, within the past 6 weeks No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: At least 6 months Hematopoietic: Hematocrit at least 30% WBC at least 3,000/mm3 Hepatic: Hepatitis B and C negative Renal: Not specified Other: Not pregnant or nursing No active serious infection No active autoimmune disease HIV negative No other malignancy within the last 5 years except squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder carcinoma, early stage prostate cancer, or noninvasive melanoma No active severe depression or psychiatric disorder with psychotic symptoms No uncontrolled thyroid abnormalities

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since prior cytotoxic drugs (except for isolated limb perfusion) Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: At least 6 months since prior radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior investigational drugs

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003715

Locations
United States, California
Cancer and Blood Institute of the Desert    
      Rancho Mirage, California, United States, 92270
United States, Connecticut
Yale Comprehensive Cancer Center    
      New Haven, Connecticut, United States, 06520-8028
United States, Florida
Columbia - HCA Cancer Research Network    
      North Miami Beach, Florida, United States, 33180
H. Lee Moffitt Cancer Center and Research Institute    
      Tampa, Florida, United States, 33612
United States, Georgia
Georgia Cancer Specialists    
      Decatur, Georgia, United States, 30033
United States, Illinois
Lutheran General Cancer Care Center    
      Park Ridge, Illinois, United States, 60068
University of Illinois at Chicago    
      Chicago, Illinois, United States, 60612
United States, Kentucky
James Graham Brown Cancer Center    
      Louisville, Kentucky, United States, 40202
United States, Michigan
Cancer and Hematology Centers of Western Michigan    
      Grand Rapids, Michigan, United States, 49546
United States, Minnesota
Hubert H. Humphrey Cancer Center    
      Robbinsdale, Minnesota, United States, 55422
United States, Missouri
Midwest Oncology Consortium    
      Kansas City, Missouri, United States, 64111
United States, New Jersey
Cancer Institute of New Jersey    
      New Brunswick, New Jersey, United States, 08901
Jersey Shore Cancer Center    
      Neptune, New Jersey, United States, 07753
United States, New York
Herbert Irving Comprehensive Cancer Center    
      New York, New York, United States, 10032
United States, Pennsylvania
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia    
      Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania Cancer Center    
      Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Palmetto Hematology/Oncology Associates    
      Spartanburg, South Carolina, United States, 29303

Sponsors and Collaborators
AVAX Technologies

Investigators
Study Chair:     Karen Doak     AVAX Technologies    
  More Information


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

Study ID Numbers:   CDR0000066824, AVAX-A/100/0101
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003715
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Interferon-alpha
BCG Vaccine
Interferon Type I, Recombinant
Interferons
Cyclophosphamide
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
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Growth Inhibitors
Angiogenesis Modulating Agents
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on September 16, 2008




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