A Prospective, Randomized, Open-Label, Comparative Clinical Trial in Post-Surgical Melanoma Patients With Either DNP-Modified Autologous Tumor Vaccine or Interferon Alpha-2b
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
A Prospective, Randomized, Open-Label, Comparative Clinical Trial in Post-Surgical Melanoma Patients With Either DNP-Modified Autologous Tumor Vaccine or Interferon Alpha-2b
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Karen Doak
Investigator Role:
Study Chair
Investigator Affiliation:
AVAX Technologies
Authority:
United States: Federal Government
Study ID:
CDR0000066824
NCT ID:
NCT00003715
Start Date:
December 1998
Completion Date:
Related Keywords:
- Melanoma (Skin)
- stage III melanoma
- Melanoma
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
| Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| University of Illinois at Chicago | Chicago, Illinois 60612 |
| Jersey Shore Cancer Center | Neptune, New Jersey 07753 |
| Hubert H. Humphrey Cancer Center | Coon Rapids, Minnesota 55433 |
| Palmetto Hematology/Oncology Associates | Spartanburg, South Carolina 29303 |
| Columbia - HCA Cancer Research Network | North Miami Beach, Florida 33180 |
| Georgia Cancer Specialists | Decatur, Georgia 30033 |
| Cancer and Blood Institute of the Desert | Rancho Mirage, California 92270 |
| Cancer and Hematology Centers of Western Michigan | Grand Rapids, Michigan 49546 |
| Midwest Oncology Consortium | Kansas City, Missouri 64111 |
