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

Sponsor

AVAX Technologies (Industry)

Overall Status

Terminated

CT.gov ID

NCT00003715

Collaborator

(none)

425

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Biological: BCG vaccine Biological: autologous tumor cell vaccine Biological: recombinant interferon alfa Drug: chemotherapy Drug: cyclophosphamide	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

425 participants

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

Study Start Date :

Dec 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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