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Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma

Phase 3
18 Years
Not Enrolling
Melanoma (Skin)

Thank you

Trial Information

Phase III Trial of High Dose Interferon Alfa 2-b Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients With High Risk Melanoma


- Compare the overall survival and disease-free survival of patients with high-risk
melanoma treated with interferon alfa vs cisplatin, vinblastine, and dacarbazine plus
interferon alfa and interleukin-2.

- Compare the toxic effects of these treatment regimens in these patients.

- Determine the relationship between minimal residual disease (MRD) status at 12 weeks
and 52 weeks and overall survival of patients treated with these regimens.

- Compare the effects of these treatment regimens on the MRD status of these patients.

- Determine the relationship between clinical characteristics (number of involved lymph
nodes, ulcerated primary, and extracapsular extension) and MRD in patients treated with
these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal
status (N1 or N2 vs N3), degree of lymph node involvement (micrometastases only vs any
macrometastases, including satellite/in-transit metastases), and ulceration of the primary
tumor (yes vs no vs unknown primary). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive interferon alfa IV on days 1-5 of weeks 1-4 followed by
interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of
disease progression or unacceptable toxicity.

- Arm II: Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on
days 1-4. Patients also receive dacarbazine IV over 1 hour on day 1, interleukin-2 IV
over 96 hours on days 1-4, and interferon alfa SC on days 1-5, 8, 10, and 12. In
addition, patients receive filgrastim (G-CSF) SC on days 6-15. Treatment repeats every
3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.

PROJECTED ACCRUAL: A total of 410 patients (205 per treatment arm) will be accrued for this
study within 3 years.

Inclusion Criteria


- Histologically proven melanoma of cutaneous origin or from unknown primary at initial
presentation of primary or first clinically detected nodal or satellite/in-transit

- No distant metastases

- No melanoma of ocular, mucosal, or other non-cutaneous origin

- One of the following criteria must apply for patients with newly diagnosed melanoma
OR a previously diagnosed primary with current subsequent, clinical, regional nodal
disease and/or satellite/in-transit disease:

- Ulcerated primary melanoma with 1 or more involved lymph nodes (micro/occult or
macro/clinically overt)

- Non-ulcerated or unknown primary melanoma with one macro/clinically overt lymph
node metastasis, including a single matted nodal mass

- No non-ulcerated or unknown primary tumor and a single micrometastatic
lymph node

- Non-ulcerated melanoma with two or more lymph node metastases (micro/occult or
macro/clinically overt) and/or matted nodes

- Any satellite/in transit metastasis with or without lymph node involvement

- Patients with recurrent disease must have recurrent disease in the regional nodal
basin of a prior complete lymphadenectomy

- Multiple regional nodal basin involvement allowed if they are appropriate anatomic
drainage basins for primary site

- Patients must be disease free at time of enrollment based on the following surgical

- Patients at initial presentation of melanoma must undergo adequate wide excision
of primary lesion

- Patients with previously diagnosed melanoma must have all disease resected with
pathologically negative margins and no disease at primary site or second
resection of primary

- Full lymphadenectomy required of all patients including those with positive
sentinel nodes or positive satellite/in-transit metastasis

- No more than 56 days since prior lymphadenectomy OR surgery to remove recurrent
disease after prior complete lymphadenectomy

- Must be willing to participate in minimal residual disease studies if registered on
the study on 3/1/2003 or later



- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified


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

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


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2 times ULN

- LDH and alkaline phosphatase no greater than 2 times ULN (above normal value requires
a contrast-enhanced CT scan or MRI of liver)

- No known recent hepatitis positivity by PCR


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 75 mL/min


- No congestive heart failure

- No coronary artery disease

- No serious cardiac arrhythmia

- No prior myocardial infarction

- Normal cardiac stress test required if any of the following are present:

- Over age 50

- Abnormal EKG

- History of cardiac disease


- No symptomatic pulmonary disease


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No autoimmune disorders or conditions of immunosuppression

- No other prior malignancy within the past 5 years except the following:

- Adequately treated basal cell or squamous cell skin cancer

- Carcinoma in situ of the cervix

- Adequately treated stage I or II cancer in remission

- HIV negative

- No known AIDS or HIV-1 associated complex


Biologic therapy:

- No prior immunotherapy, including interferon, interleukin, levamisole, or other
biologic response modifiers

- No other concurrent biologic therapy


- No prior chemotherapy (including infusion or perfusion therapy)

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent systemic corticosteroids or topical steroid creams

- Concurrent steroid antihistamines allowed if no alternative

- No concurrent hormonal therapy


- No prior radiotherapy

- Prior postlumpectomy radiotherapy for breast cancer allowed

- No concurrent radiotherapy


- See Disease Characteristics

- No concurrent surgery


- No concurrent anti-hypertensive medications (arm II only)

- No concurrent immunosuppressive agents

- No other concurrent anticancer therapy

- Antihistamines allowed if no alternative medication suitable

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

5-year Overall Survival

Outcome Description:

Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.

Outcome Time Frame:

Every three months for a year, every six months for years 2-5, annual for years 5-10

Safety Issue:


Principal Investigator

Lawrence E. Flaherty, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

August 2000

Completion Date:

July 2012

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • recurrent melanoma
  • Melanoma



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Hurley Medical Center Flint, Michigan  48503
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Kansas City Kansas City, Missouri  64131
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CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
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CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center Farmington, Connecticut  06360-2875
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus New Britain, Connecticut  06050
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Evanston Northwestern Healthcare - Evanston Hospital Evanston, Illinois  60201-1781
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Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
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Tufts-NEMC Cancer Center Boston, Massachusetts  02111
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Bronson Methodist Hospital Kalamazoo, Michigan  49007
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
Borgess Medical Center Kalamazooaa, Michigan  49001
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St. John Macomb Hospital Warren, Michigan  48093
MeritCare Bemidji Bemidji, Minnesota  56601
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Fairview Southdale Hospital Edina, Minnesota  55435
Mercy and Unity Cancer Center at Unity Hospital Fridley, Minnesota  55432
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Meeker County Memorial Hospital Lichfield, Minnesota  55355
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HealthEast Cancer Care at St. John's Hospital Maplewood, Minnesota  55109
Hennepin County Medical Center - Minneapolis Minneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
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Park Nicollet Cancer Center St. Louis Park, Minnesota  55416
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Ridgeview Medical Center Waconia, Minnesota  55387
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HealthEast Cancer Care at Woodwinds Health Campus Woodbury, Minnesota  55125
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Avera Cancer Institute Sioux Falls, South Dakota  57105
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CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
Methodist Medical Center of Illinois Peoria, Illinois  61636
Memorial Hospital of South Bend South Bend, Indiana  46601
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CCOP - Columbus Columbus, Ohio  43206
CCOP - Greenville Greenville, South Carolina  29615
Harrington Cancer Center Amarillo, Texas  79106
CCOP - Western Regional, Arizona Phoenix, Arizona  85006-2726
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of Iowa Iowa City, Iowa  52242-1002
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
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Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
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All Children's Hospital St. Petersburg, Florida  33701
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St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
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Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
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Phoenix Children's Hospital Phoenix, Arizona  85016-7710
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Winship Cancer Institute of Emory University Atlanta, Georgia  30322
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Mount Nittany Medical Center State College, Pennsylvania  16803
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Perry Memorial Hospital Princeton, Illinois  61356
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St. Margaret's Hospital Spring Valley, Illinois  61362
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Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
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Feist-Weiller Cancer Center at Louisiana State University Health Sciences Shreveport, Louisiana  71130-3932
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Legacy Meridian Park Hospital Tualatin, Oregon  97062
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St. Francis Hospital Federal Way, Washington  98003
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Billings Clinic - Downtown Billings, Montana  59107-7000
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St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
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Grant Medical Center Cancer Care Columbus, Ohio  43215
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Adventist Medical Center Portland, Oregon  97216
Legacy Good Samaritan Hospital & Comprehensive Cancer Center Portland, Oregon  97210
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St. Joseph Cancer Center Bellingham, Washington  98225
Providence Centralia Hospital Centralia, Washington  98531-9027
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Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham Birmingham, Alabama  35294
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Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Martha Jefferson Hospital Cancer Care Center Charlottesville, Virginia  22901
Sherman Hospital Elgin, Illinois  60120-2198
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Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Billings Clinic Cancer Center Billings, Montana  59107-5100
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Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
Scripps Cancer Center - San Diego San Diego, California  92121
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
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Boston University Cancer Research Center Boston, Massachusetts  02118
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Lovelace Medical Center - Gibson Albuquerque, New Mexico  87108
University of Tennessee Cancer Institute - Memphis Memphis, Tennessee  38104