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

This study has been terminated.
(Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated)
Sponsor:
Information provided by (Responsible Party):
AVAX Technologies
ClinicalTrials.gov Identifier:
NCT00003715
First received: November 1, 1999
Last updated: July 10, 2013
Last verified: July 2013
  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)
Biological: BCG vaccine
Biological: autologous tumor cell vaccine
Biological: recombinant interferon alfa
Drug: chemotherapy
Drug: cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AVAX Technologies:

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
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
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
Jersey Shore Cancer Center
Neptune, New Jersey, United States, 07753
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
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

No publications provided

Responsible Party: AVAX Technologies
ClinicalTrials.gov Identifier: NCT00003715     History of Changes
Other Study ID Numbers: CDR0000066824, AVAX-A/100/0101
Study First Received: November 1, 1999
Last Updated: July 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AVAX Technologies:
stage III 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
Interferon-alpha
Interferon Alfa-2a
Interferons
BCG Vaccine
Cyclophosphamide
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2014