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

NCT00003647 | Completed Phase 3 DMC

• 2 other identifiers: CDR0000066736VCL-1005-301
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 44

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.

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

Interventions

allovectin-7 DRUG

allovectin-7/dacarbazine DRUG

dacarbazine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vical: lead

Study Sites (44)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Comprehensive Blood and Cancer Center

Bakersfield, California, 93309, United States

Location

Scripps Memorial Hospitals-Stevens Cancer Center - Encinitas

Encinitas, California, 92023, United States

Location

Kaiser Permanente-Southern California Permanente Medical Group

San Diego, California, 92120, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Georgia Cancer Specialists

Decatur, Georgia, 30033, United States

Location

Georgia Cancer Specialists, P.C.

East Point, Georgia, 30344, United States

Location

St. Francis Medical Center

Honolulu, Hawaii, 96817, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Cancer Care Center for Southern Indiana

Bloomington, Indiana, 47403, United States

Location

Cancer Care Center

New Albany, Indiana, 47150, United States

Location

Oncology and Hematology Associates

Westwood, Kansas, 66205, United States

Location

Lucille Parker Markey Cancer Center, University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112-2822, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Providence Hospital Cancer Center

Southfield, Michigan, 48075, United States

Location

Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407, United States

Location

North Memorial Health Care

Robbinsdale, Minnesota, 55422, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Park Nicollet Clinic

Saint Louis Park, Minnesota, 55416, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

Missouri Baptist Cancer Center

St Louis, Missouri, 63131, United States

Location

Billings Interhospital Oncology Project

Billings, Montana, 59101, United States

Location

Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

HemOnCare, P.C.

Brooklyn, New York, 11235, United States

Location

Arena Oncology Associates

Great Neck, New York, 11021, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Mid Dakota Clinic, P.C.

Bismarck, North Dakota, 58501, United States

Location

Mid-Ohio Oncology/Hematology, Inc.

Columbus, Ohio, 43222, United States

Location

Toledo Clinic, Inc.

Toledo, Ohio, 43623, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Danville Hematology and Oncology, Inc.

Danville, Virginia, 24541, United States

Location

Cancer Treatment Centers of America in Hampton Roads

Portsmouth, Virginia, 23704, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Melanoma; Neoplasms; Skin Neoplasms

Interventions

Allovectin-7; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Cherie Smith

  Vical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 23, 2004
• Study Start: July 1, 1998
• Study Completion: September 1, 2002
• Last Updated: July 25, 2008

Record last verified: 2008-07

Locations

US (44)