Back to resultsChemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
Primary Purpose
Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
allovectin-7
allovectin-7/dacarbazine
dacarbazine
Sponsored by
About this trial
This is an interventional treatment trial for Stage IV Melanoma focused on measuring adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage III melanoma, stage IV melanoma, stage, melanoma
Eligibility Criteria
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
Sites / Locations
- University of Arkansas for Medical Sciences
- Comprehensive Blood and Cancer Center
- Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas
- Kaiser Permanente-Southern California Permanente Medical Group
- Yale Comprehensive Cancer Center
- Washington Cancer Institute
- Mount Sinai Comprehensive Cancer Center
- H. Lee Moffitt Cancer Center and Research Institute
- Georgia Cancer Specialists
- Georgia Cancer Specialists, P.C.
- St. Francis Medical Center
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
- Lutheran General Hospital
- Cancer Care Center for Southern Indiana
- Cancer Care Center
- Oncology and Hematology Associates
- Lucille Parker Markey Cancer Center, University of Kentucky
- Louisiana State University School of Medicine
- Franklin Square Hospital Center
- Providence Hospital Cancer Center
- Virginia Piper Cancer Institute
- North Memorial Health Care
- Mayo Clinic Cancer Center
- Park Nicollet Clinic
- St. Louis University Health Sciences Center
- Missouri Baptist Cancer Center
- Billings Interhospital Oncology Project
- Bergan Mercy Medical Center
- Norris Cotton Cancer Center
- HemOnCare, P.C.
- Arena Oncology Associates
- Beth Israel Medical Center
- Mount Sinai School of Medicine
- Comprehensive Cancer Center at Wake Forest University
- Mid Dakota Clinic, P.C.
- Mid-Ohio Oncology/Hematology, Inc.
- Toledo Clinic, Inc.
- University of Pennsylvania Cancer Center
- Cancer Centers of the Carolinas
- Huntsman Cancer Institute
- Danville Hematology and Oncology, Inc.
- Cancer Treatment Centers of America in Hampton Roads
- Seattle Cancer Care Alliance
- Medical College of Wisconsin
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00003647
Brief Title
Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
Official Title
Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Vical
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
II. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma
Keywords
adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage III melanoma, stage IV melanoma, stage, melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
allovectin-7
Intervention Type
Drug
Intervention Name(s)
allovectin-7/dacarbazine
Intervention Type
Drug
Intervention Name(s)
dacarbazine
10. Eligibility
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cherie Smith
Organizational Affiliation
Vical
Official's Role
Study Chair
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas
City
Encinitas
State/Province
California
ZIP/Postal Code
92023
Country
United States
Facility Name
Kaiser Permanente-Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
Washington Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Georgia Cancer Specialists
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Georgia Cancer Specialists, P.C.
City
East Point
State/Province
Georgia
ZIP/Postal Code
30344
Country
United States
Facility Name
St. Francis Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Cancer Care Center for Southern Indiana
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Cancer Care Center
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Oncology and Hematology Associates
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Lucille Parker Markey Cancer Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Louisiana State University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2822
Country
United States
Facility Name
Franklin Square Hospital Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Providence Hospital Cancer Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
North Memorial Health Care
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Park Nicollet Clinic
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
Missouri Baptist Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Billings Interhospital Oncology Project
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Bergan Mercy Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
HemOnCare, P.C.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Arena Oncology Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Mid Dakota Clinic, P.C.
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Mid-Ohio Oncology/Hematology, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Toledo Clinic, Inc.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Danville Hematology and Oncology, Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Cancer Treatment Centers of America in Hampton Roads
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23704
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
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