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

July 23, 2008 updated by: Vical

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

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.

Study Overview

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Cherie Smith, Vical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Study Completion (Actual)

September 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

March 22, 2004

First Posted (Estimate)

March 23, 2004

Study Record Updates

Last Update Posted (Estimate)

July 25, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

July 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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