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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003647
Recruitment Status : Completed
First Posted : March 23, 2004
Last Update Posted : July 25, 2008
Information provided by:

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.

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.


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

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma
Study Start Date : July 1998
Actual Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Dacarbazine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)


--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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003647

Hide Hide 44 study locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas
Encinitas, California, United States, 92023
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States, 92120
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, Florida
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Georgia Cancer Specialists
Decatur, Georgia, United States, 30033
Georgia Cancer Specialists, P.C.
East Point, Georgia, United States, 30344
United States, Hawaii
St. Francis Medical Center
Honolulu, Hawaii, United States, 96817
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
United States, Indiana
Cancer Care Center for Southern Indiana
Bloomington, Indiana, United States, 47403
Cancer Care Center
New Albany, Indiana, United States, 47150
United States, Kansas
Oncology and Hematology Associates
Westwood, Kansas, United States, 66205
United States, Kentucky
Lucille Parker Markey Cancer Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0093
United States, Louisiana
Louisiana State University School of Medicine
New Orleans, Louisiana, United States, 70112-2822
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
United States, Michigan
Providence Hospital Cancer Center
Southfield, Michigan, United States, 48075
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
North Memorial Health Care
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
Park Nicollet Clinic
St. Louis Park, Minnesota, United States, 55416
United States, Missouri
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
United States, Montana
Billings Interhospital Oncology Project
Billings, Montana, United States, 59101
United States, Nebraska
Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
HemOnCare, P.C.
Brooklyn, New York, United States, 11235
Arena Oncology Associates
Great Neck, New York, United States, 11021
Beth Israel Medical Center
New York, New York, United States, 10003
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, North Dakota
Mid Dakota Clinic, P.C.
Bismarck, North Dakota, United States, 58501
United States, Ohio
Mid-Ohio Oncology/Hematology, Inc.
Columbus, Ohio, United States, 43222
Toledo Clinic, Inc.
Toledo, Ohio, United States, 43623
United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
Danville Hematology and Oncology, Inc.
Danville, Virginia, United States, 24541
Cancer Treatment Centers of America in Hampton Roads
Portsmouth, Virginia, United States, 23704
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
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Study Chair: Cherie Smith Vical

Layout table for additonal information Identifier: NCT00003647    
Obsolete Identifiers: NCT00416416
Other Study ID Numbers: CDR0000066736
First Posted: March 23, 2004    Key Record Dates
Last Update Posted: July 25, 2008
Last Verified: July 2008
Keywords provided by Vical:
adult solid tumor
body system/site cancer
recurrent melanoma
skin tumor
solid tumor
stage III melanoma
stage IV melanoma
stage, melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas