Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma

Sponsor

Vical (Industry)

Overall Status

Completed

CT.gov ID

NCT00003647

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.

Condition or Disease	Intervention/Treatment	Phase
Stage IV Melanoma Stage III Melanoma Recurrent Melanoma	Drug: allovectin-7 Drug: allovectin-7/dacarbazine Drug: dacarbazine	Phase 3

Detailed Description

OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.

Determine the benefits, risks, and side effects of these regimens in this patient population.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms.

Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.

Patients with stable or responding disease may receive additional courses every 28 days.

Patients are followed every 4 months.

PROJECTED ACCRUAL:

A total of 280 patients (140 in each arm) will be accrued for this study.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma

Study Start Date :

Jul 1, 1998

Actual Study Completion Date :

Sep 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for which surgery is not deemed to be a curative option
Dacarbazine is indicated as first line chemotherapy
At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2
No history of brain metastases

--Prior/Concurrent Therapy--

Biologic therapy: At least 4 weeks since prior biologic therapy
Chemotherapy: See Disease Characteristics; No prior chemotherapy
Endocrine therapy: No concurrent immunosuppressive drugs
Radiotherapy: At least 4 weeks since prior radiotherapy
Surgery: At least 2 weeks since prior major surgery
Other: No other concurrent anticancer drug therapy or experimental therapy

--Patient Characteristics--

Age: 18 and over
Performance status: Karnofsky 80-100%
Life expectancy: At least 24 weeks
Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN
Renal: Creatinine no greater than 2.0 mg/dL
Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease
Other: HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	Comprehensive Blood and Cancer Center	Bakersfield	California	United States	93309
3	Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas	Encinitas	California	United States	92023
4	Kaiser Permanente-Southern California Permanente Medical Group	San Diego	California	United States	92120
5	Yale Comprehensive Cancer Center	New Haven	Connecticut	United States	06520-8028
6	Washington Cancer Institute	Washington	District of Columbia	United States	20010
7	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida	United States	33140
8	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
9	Georgia Cancer Specialists	Decatur	Georgia	United States	30033
10	Georgia Cancer Specialists, P.C.	East Point	Georgia	United States	30344
11	St. Francis Medical Center	Honolulu	Hawaii	United States	96817
12	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois	United States	60611-3013
13	Lutheran General Hospital	Park Ridge	Illinois	United States	60068
14	Cancer Care Center for Southern Indiana	Bloomington	Indiana	United States	47403
15	Cancer Care Center	New Albany	Indiana	United States	47150
16	Oncology and Hematology Associates	Westwood	Kansas	United States	66205
17	Lucille Parker Markey Cancer Center, University of Kentucky	Lexington	Kentucky	United States	40536-0093
18	Louisiana State University School of Medicine	New Orleans	Louisiana	United States	70112-2822
19	Franklin Square Hospital Center	Baltimore	Maryland	United States	21237
20	Providence Hospital Cancer Center	Southfield	Michigan	United States	48075
21	Virginia Piper Cancer Institute	Minneapolis	Minnesota	United States	55407
22	North Memorial Health Care	Robbinsdale	Minnesota	United States	55422
23	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
24	Park Nicollet Clinic	St. Louis Park	Minnesota	United States	55416
25	St. Louis University Health Sciences Center	Saint Louis	Missouri	United States	63110-0250
26	Missouri Baptist Cancer Center	Saint Louis	Missouri	United States	63131
27	Billings Interhospital Oncology Project	Billings	Montana	United States	59101
28	Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
29	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756-0002
30	HemOnCare, P.C.	Brooklyn	New York	United States	11235
31	Arena Oncology Associates	Great Neck	New York	United States	11021
32	Beth Israel Medical Center	New York	New York	United States	10003
33	Mount Sinai School of Medicine	New York	New York	United States	10029
34	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
35	Mid Dakota Clinic, P.C.	Bismarck	North Dakota	United States	58501
36	Mid-Ohio Oncology/Hematology, Inc.	Columbus	Ohio	United States	43222
37	Toledo Clinic, Inc.	Toledo	Ohio	United States	43623
38	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104-4283
39	Cancer Centers of the Carolinas	Greenville	South Carolina	United States	29605
40	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
41	Danville Hematology and Oncology, Inc.	Danville	Virginia	United States	24541
42	Cancer Treatment Centers of America in Hampton Roads	Portsmouth	Virginia	United States	23704
43	Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
44	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226