Clinical trial NCT00003647: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Vical
Sponsor class: INDUSTRY
First posted: 2004-03-23
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Primary purpose: TREATMENT

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.

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

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