Melanoma Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 3

Study ID:

NCT00003647

Recruitment Status:

Completed

Sponsor:

Vical

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 44 Locations for this study

See Locations Near You

University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Comprehensive Blood and Cancer Center
Bakersfield California, 93309, United States
Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas
Encinitas California, 92023, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego California, 92120, United States
Yale Comprehensive Cancer Center
New Haven Connecticut, 06520, United States
Washington Cancer Institute
Washington District of Columbia, 20010, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Georgia Cancer Specialists
Decatur Georgia, 30033, United States
Georgia Cancer Specialists, P.C.
East Point Georgia, 30344, United States
St. Francis Medical Center
Honolulu Hawaii, 96817, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago Illinois, 60611, United States
Lutheran General Hospital
Park Ridge Illinois, 60068, United States
Cancer Care Center for Southern Indiana
Bloomington Indiana, 47403, United States
Cancer Care Center
New Albany Indiana, 47150, United States
Oncology and Hematology Associates
Westwood Kansas, 66205, United States
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington Kentucky, 40536, United States
Louisiana State University School of Medicine
New Orleans Louisiana, 70112, United States
Franklin Square Hospital Center
Baltimore Maryland, 21237, United States
Providence Hospital Cancer Center
Southfield Michigan, 48075, United States
Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
North Memorial Health Care
Robbinsdale Minnesota, 55422, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Park Nicollet Clinic
St. Louis Park Minnesota, 55416, United States
St. Louis University Health Sciences Center
Saint Louis Missouri, 63110, United States
Missouri Baptist Cancer Center
Saint Louis Missouri, 63131, United States
Billings Interhospital Oncology Project
Billings Montana, 59101, United States
Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Norris Cotton Cancer Center
Lebanon New Hampshire, 03756, United States
HemOnCare, P.C.
Brooklyn New York, 11235, United States
Arena Oncology Associates
Great Neck New York, 11021, United States
Beth Israel Medical Center
New York New York, 10003, United States
Mount Sinai School of Medicine
New York New York, 10029, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
Mid Dakota Clinic, P.C.
Bismarck North Dakota, 58501, United States
Mid-Ohio Oncology/Hematology, Inc.
Columbus Ohio, 43222, United States
Toledo Clinic, Inc.
Toledo Ohio, 43623, United States
University of Pennsylvania Cancer Center
Philadelphia Pennsylvania, 19104, United States
Cancer Centers of the Carolinas
Greenville South Carolina, 29605, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Danville Hematology and Oncology, Inc.
Danville Virginia, 24541, United States
Cancer Treatment Centers of America in Hampton Roads
Portsmouth Virginia, 23704, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Study ID:

NCT00003647

Recruitment Status:

Completed

Sponsor:


Vical

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider