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

Stage IV Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003647
• Other study ID #: CDR0000066736
• Secondary ID: VCL-1005-301
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: July 23, 2008
• Start date: July 1998
• Est. completion date: September 2002

Study information

• Verified date: July 2008
• Source: Vical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00416416

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2002
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Recurrent Melanoma
• Stage III Melanoma
• Stage IV Melanoma

Intervention

Drug:
• allovectin-7

• allovectin-7/dacarbazine

• dacarbazine

Locations

Country	Name	City	State
United States	Comprehensive Blood and Cancer Center	Bakersfield	California
United States	Franklin Square Hospital Center	Baltimore	Maryland
United States	Billings Interhospital Oncology Project	Billings	Montana
United States	Mid Dakota Clinic, P.C.	Bismarck	North Dakota
United States	Cancer Care Center for Southern Indiana	Bloomington	Indiana
United States	HemOnCare, P.C.	Brooklyn	New York
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	Mid-Ohio Oncology/Hematology, Inc.	Columbus	Ohio
United States	Danville Hematology and Oncology, Inc.	Danville	Virginia
United States	Georgia Cancer Specialists	Decatur	Georgia
United States	Georgia Cancer Specialists, P.C.	East Point	Georgia
United States	Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas	Encinitas	California
United States	Arena Oncology Associates	Great Neck	New York
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	St. Francis Medical Center	Honolulu	Hawaii
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Lucille Parker Markey Cancer Center, University of Kentucky	Lexington	Kentucky
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Virginia Piper Cancer Institute	Minneapolis	Minnesota
United States	Cancer Care Center	New Albany	Indiana
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	Louisiana State University School of Medicine	New Orleans	Louisiana
United States	Beth Israel Medical Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Bergan Mercy Medical Center	Omaha	Nebraska
United States	Lutheran General Hospital	Park Ridge	Illinois
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Cancer Treatment Centers of America in Hampton Roads	Portsmouth	Virginia
United States	North Memorial Health Care	Robbinsdale	Minnesota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Missouri Baptist Cancer Center	Saint Louis	Missouri
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Kaiser Permanente-Southern California Permanente Medical Group	San Diego	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Providence Hospital Cancer Center	Southfield	Michigan
United States	Park Nicollet Clinic	St. Louis Park	Minnesota
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Toledo Clinic, Inc.	Toledo	Ohio
United States	Washington Cancer Institute	Washington	District of Columbia
United States	Oncology and Hematology Associates	Westwood	Kansas
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Vical

Country where clinical trial is conducted

United States,