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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00006237




Registration number
NCT00006237
Ethics application status
Date submitted
11/09/2000
Date registered
27/01/2003
Date last updated
25/03/2015

Titles & IDs
Public title
S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
Scientific title
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
Secondary ID [1] 0 0
U10CA032102
Secondary ID [2] 0 0
S0008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma (Skin) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - interleukin-2
Other interventions - filgrastim
Other interventions - interferon alfa
Treatment: Drugs - cisplatin
Treatment: Drugs - dacarbazine
Treatment: Drugs - vinblastine

Active Comparator: 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.

Experimental: 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.


Other interventions: interleukin-2
Given IV

Other interventions: filgrastim
Given subcutaneously

Other interventions: interferon alfa
Given IV and subcutaneously

Treatment: Drugs: cisplatin
Given IV

Treatment: Drugs: dacarbazine
Given IV

Treatment: Drugs: vinblastine
Given IV

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
5-year Overall Survival - 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.
Timepoint [1] 0 0
Every three months for a year, every six months for years 2-5, annual for years 5-10
Primary outcome [2] 0 0
5-year Relapse-Free Survival - Measured from date of registration to date of first observation of progressive disease or death due to any cause.
Timepoint [2] 0 0
Every three months for the first year, every 6 months for years 2-5, annually for years 6-10
Secondary outcome [1] 0 0
Toxicity - Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
Timepoint [1] 0 0
While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter.

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

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

- 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
criteria:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

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

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

Hepatic:

- 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

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 75 mL/min

Cardiovascular:

- 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

Pulmonary:

- No symptomatic pulmonary disease

Other:

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

- No other concurrent biologic therapy

Chemotherapy:

- 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

Radiotherapy:

- No prior radiotherapy

- Prior postlumpectomy radiotherapy for breast cancer allowed

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

- No concurrent surgery

Other:

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

- No concurrent immunosuppressive agents

- No other concurrent anticancer therapy

- Antihistamines allowed if no alternative medication suitable
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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West Virginia
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Wisconsin
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Wyoming

Funding & Sponsors
Primary sponsor type
Other
Name
Southwest Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Eastern Cooperative Oncology Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cancer and Leukemia Group B
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Children's Oncology Group
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is
not yet known whether interferon alfa is more effective with or without combination
chemotherapy and interleukin-2 for melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or
without combination chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus
interleukin-2, in treating patients who have melanoma.
Trial website
https://clinicaltrials.gov/show/NCT00006237
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lawrence E. Flaherty, MD
Address 0 0
Barbara Ann Karmanos Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications