Clinical trial NCT00003715: Vaccine Therapy Compared With Interferon Alfa in Treating Patients With Stage III Melanoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: stage III melanoma
Lead sponsor: AVAX Technologies
Sponsor class: INDUSTRY
First posted: 2004-04-23
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Cancer and Blood Institute of the Desert
state: California
city: New Haven
country: United States
facility: Yale Comprehensive Cancer Center
state: Connecticut
city: North Miami Beach
country: United States
facility: Columbia - HCA Cancer Research Network
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Decatur
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Cancer Care Center
state: Illinois
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Robbinsdale
country: United States
facility: Hubert H. Humphrey Cancer Center
state: Minnesota
city: Kansas City
country: United States
facility: Midwest Oncology Consortium
state: Missouri
city: Neptune
country: United States
facility: Jersey Shore Cancer Center
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Spartanburg
country: United States
facility: Palmetto Hematology/Oncology Associates
state: South Carolina
Study officials:
affiliation: AVAX Technologies
name: Karen Doak
role: STUDY_CHAIR
References: