Know Cancer

forgot password

A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma

Phase 3
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma


- Compare response rate, duration of response, and survival rate in patients with
metastatic malignant melanoma treated with cisplatin, vinblastine, and dacarbazine with
or without interleukin-2 and interferon alfa-2b.

- Determine the toxic effects of these regimens in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to performance status
(0 vs 1), prior interferon (yes vs no), and number of involved sites. Patients are
randomized to one of two treatment arms.

- Arm I: Patients receive cisplatin IV over 30 minutes daily immediately followed by
vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 60 minutes on day
1 following vinblastine.

- Arm II: Patients receive treatment as in arm I. Patients also receive interleukin 2
(IL-2) IV continuously on days 1-4 and interferon alfa-2b subcutaneously (SC) daily
before IL-2 on days 1-4 and after IL-2 on day 5, followed by filgrastim (G-CSF) (SC)
daily on days 7-16.

Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed at 6 weeks, every 3 months for 18 months, every 6 months for 18
months, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 482 patients will be accrued for this study within 3.5 years.

Inclusion Criteria


- Histologically confirmed surgically incurable metastatic malignant melanoma

- Measurable disease

- No active brain metastases or edema

- No leptomeningeal disease

- No ocular melanoma



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL


- Bilirubin no greater than 1.5 mg/dL

- SGOT less than 3 times the upper limit of normal unless due to liver metastases


- Creatinine less than 1.5 mg/dL OR

- Creatinine clearance at least 75 mL/min


- No congestive heart failure

- No symptoms of coronary artery disease

- No serious cardiac arrhythmias

- No prior myocardial infarction on EKG

- Normal cardiac stress test required for the following:

- Over 50 years of age

- Abnormal EKG

- Prior history of cardiac disease


- No symptomatic pulmonary disease

- FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with
history of pulmonary symptoms


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No significant infection

- HIV negative

- No other prior malignancy within the past 5 years except basal cell or squamous cell
skin cancer or carcinoma in situ of the cervix

- No organ allografts

- No significant disease other than malignancy

- No seizure disorder


Biologic therapy:

- No prior interleukin-2 therapy for metastatic disease

- At least 4 weeks since prior vaccine therapy

- At least 4 weeks since prior adjuvant immunotherapy


- No prior chemotherapy for disease

Endocrine therapy:

- No concurrent corticosteroids


- No prior radiation therapy to measurable disease site unless disease is clearly

- At least 4 weeks since prior radiation therapy for local control or palliation and


- Recovered from prior surgery


- No prior systemic therapy for metastatic disease

- At least 3 months since definitive therapy for brain metastases

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:


Principal Investigator

Michael B. Atkins, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Tufts Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 1997

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • Melanoma



Arizona Cancer Center Tucson, Arizona  85724
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of California Davis Medical Center Sacramento, California  95817
CCOP - Wichita Wichita, Kansas  67214-3882
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
CCOP - Duluth Duluth, Minnesota  55805
Loyola University Medical Center Maywood, Illinois  60153
CCOP - Toledo Community Hospital Oncology Program Toledo, Ohio  43623-3456
Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Tulane University School of Medicine New Orleans, Louisiana  70112
Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain, Massachusetts  02130
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
St. Louis University Health Sciences Center Saint Louis, Missouri  63110-0250
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
Veterans Affairs Medical Center - Albany Albany, New York  12208
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Columbia River Program Portland, Oregon  97213
CCOP - Greenville Greenville, South Carolina  29615
University of Texas Medical Branch Galveston, Texas  77555-1329
Swedish Cancer Institute Seattle, Washington  98104
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
CCOP - Scott and White Hospital Temple, Texas  76508
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - Gulf Coast Mobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
Cancer Center and Beckman Research Institute, City of Hope Duarte, California  91010-3000
Veterans Affairs Medical Center - West Los Angeles Los Angeles, California  90073
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Dwight David Eisenhower Army Medical Center Fort Gordon, Georgia  30905-5650
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Boston Medical Center Boston, Massachusetts  02118
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Providence Hospital - Southfield Southfield, Michigan  48075-9975
Veterans Affairs Medical Center - Biloxi Biloxi, Mississippi  39531-2410
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Veterans Affairs Medical Center - Kansas City Kansas City, Missouri  64128
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Herbert Irving Comprehensive Cancer Center New York, New York  10032
University of Rochester Medical Center Rochester, New York  14642
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Oklahoma Medical Research Foundation Oklahoma City, Oklahoma  73104
Veterans Affairs Medical Center - Oklahoma City Oklahoma City, Oklahoma  73104
OHSU Cancer Institute Portland, Oregon  97239
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Veterans Affairs Medical Center - Charleston Charleston, South Carolina  29401-5799
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - Houston Houston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Madigan Army Medical Center Tacoma, Washington  98431-5048