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

NCT00003715 | Terminated Phase 2

• 2 other identifiers: CDR0000066824AVAX-A/100/0101
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma

Interventions

BCG vaccine BIOLOGICAL

autologous tumor cell vaccine BIOLOGICAL

recombinant interferon alfa BIOLOGICAL

chemotherapy DRUG

cyclophosphamide DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AVAX Technologies: lead

Study Sites (17)

Cancer and Blood Institute of the Desert

Rancho Mirage, California, 92270, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Columbia - HCA Cancer Research Network

North Miami Beach, Florida, 33180, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Georgia Cancer Specialists

Decatur, Georgia, 30033, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Lutheran General Cancer Care Center

Park Ridge, Illinois, 60068, United States

Location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49546, United States

Location

Hubert H. Humphrey Cancer Center

Robbinsdale, Minnesota, 55422, United States

Location

Midwest Oncology Consortium

Kansas City, Missouri, 64111, United States

Location

Jersey Shore Cancer Center

Neptune City, New Jersey, 07753, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Palmetto Hematology/Oncology Associates

Spartanburg, South Carolina, 29303, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

BCG Vaccine; FANG vaccine; Interferon-alpha; Drug Therapy; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Therapeutics; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Karen Doak

  AVAX Technologies

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 23, 2004
• Study Start: December 1, 1998
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

US (17)