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


Phase 3
18 Years
N/A
Not Enrolling
Both
Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Cherie Smith

Investigator Role:

Study Chair

Investigator Affiliation:

Vical

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066736

NCT ID:

NCT00003647

Start Date:

July 1998

Completion Date:

September 2002

Related Keywords:

  • Stage IV Melanoma
  • Stage III Melanoma
  • Recurrent Melanoma
  • adult solid tumor
  • body system/site cancer
  • cancer
  • melanoma
  • recurrent melanoma
  • skin tumor
  • solid tumor
  • stage III melanoma
  • stage IV melanoma
  • stage, melanoma
  • Melanoma

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Mount Sinai School of MedicineNew York, New York  10029
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
Bergan Mercy Medical CenterOmaha, Nebraska  68124
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Medical College of WisconsinMilwaukee, Wisconsin  53226
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
Beth Israel Medical CenterNew York, New York  10003
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Lucille Parker Markey Cancer Center, University of KentuckyLexington, Kentucky  40536-0093
Franklin Square Hospital CenterBaltimore, Maryland  21237
Lutheran General HospitalPark Ridge, Illinois  60068
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Louisiana State University School of MedicineNew Orleans, Louisiana  70112-2822
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Providence Hospital Cancer CenterSouthfield, Michigan  48075
Georgia Cancer SpecialistsDecatur, Georgia  30033
Danville Hematology and Oncology, Inc.Danville, Virginia  24541
Park Nicollet ClinicSt. Louis Park, Minnesota  55416
Mid Dakota Clinic, P.C.Bismarck, North Dakota  58501
Toledo Clinic, Inc.Toledo, Ohio  43623
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Cancer Care Center for Southern IndianaBloomington, Indiana  47403
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Scripps Memorial Hospitals-Stevens Cancer Center - EncinitasEncinitas, California  92023
Washington Cancer InstituteWashington, District of Columbia  20010
Georgia Cancer Specialists, P.C.East Point, Georgia  30344
St. Francis Medical CenterHonolulu, Hawaii  96817
Cancer Care CenterNew Albany, Indiana  47150
Oncology and Hematology AssociatesWestwood, Kansas  66205
North Memorial Health CareRobbinsdale, Minnesota  55422
Billings Interhospital Oncology ProjectBillings, Montana  59101
HemOnCare, P.C.Brooklyn, New York  11235
Arena Oncology AssociatesGreat Neck, New York  11021
Mid-Ohio Oncology/Hematology, Inc.Columbus, Ohio  43222
Cancer Treatment Centers of America in Hampton RoadsPortsmouth, Virginia  23704
Seattle Cancer Care AllianceSeattle, Washington  98109