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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00003641




Trial ID
NCT00003641
Ethics application status
Date submitted
1/11/1999
Date registered
26/01/2003
Date last updated
31/03/2016

Titles & IDs
Public title
High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma
Scientific title
Phase III Randomized Study of Four Weeks of High Dose Interferon Alfa-2b in Stage T2bN0, T3a-bN0, T4a-bN0, and T1-4, N1a,2a (Microscopic) Melanoma
Secondary ID [1] 0 0
E1697
Secondary ID [2] 0 0
E1697
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 - interferon alfa-2b
Other interventions - observation

Other: Observation - Patients undergo observation for 4 weeks.

Experimental: Interferon Alfa-2b - Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.


Other interventions: interferon alfa-2b
Given IV

Other interventions: observation
Patients undergo observation for 4 weeks.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
5-year Relapse-free Survival Rate - Relapse-free survival (RFS) was defined as time from randomization to disease relapse or death from any cause, whichever occurred first. Patients without disease relapse were censored at last disease assessment date known of free of relapse. Kaplan-Meier method was used to estimate 5-year RFS rate in the intent-to-treat (ITT) patients.
Timepoint [1] 0 0
assessed every 3 months for 2 years, every 6 months for 3 years
Secondary outcome [1] 0 0
5-year Overall Survival Rate - Overall survival (OS) was defined as time from randomization to death from any cause. Patients still alive were censored at last known alive date. Kaplan-Meier method was used to estimate 5-year OS rate in the ITT patients.
Timepoint [1] 0 0
assessed every 3 months for 2 years, every 6 months for 3 years

Eligibility
Key inclusion criteria
- Histologically confirmed primary melanoma of cutaneous origin

- Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)

- Clinically negative regional lymph node pathologic status unknown OR

- Histologically negative regional lymph nodes

- Stage III (T4 N0 M0)

- Greater than 4.0 mm Breslow depth OR

- Stage III (T1-4 N1)

- One lymph node positive microscopically

- Patients must meet at least 1 of the following criteria:

- T2b N0 - primary melanoma 1.01-2.0 mm with ulceration, node negative

- T3a-b N0 - primary melanoma 2.01-4.0 mm with and without ulceration, node
negative

- T4a-b N0 - primary melanoma > 4.0 mm with or without ulceration, node negative

- T1a N1a-2a (microscopic) - primary melanoma of any thickness with microscopically
positive lymph node (any number)

- Patients with a positive sentinel node should undergo complete lymphadenectomy of the
nodal basin prior to study

- Must complete all primary therapy (wide excision with or without lymphadenectomy) and
be randomized in this study within 84 days of wide excision

- Must have undergone an adequate wide excision of the primary lesion

- Age 18 and over (For ECOG patients only, patients must be >=10 years)

- Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1

- Adequate hematopoietic, hepatic, and renal function based on the following tests:

- White blood cell (WBC) cout at least 3,000/mm^3

- Platelet count at least 125,000/mm^3

- Hematocrit at least 30%

- Bilirubin no greater than 2 times upper limit of normal (ULN)

- Aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and alkaline
phosphatase no greater than 2 times ULN

- If lactate dehydrogenase or alkaline phosphatase is above normal, a
contrast-enhanced computed tomography (CT) scan or Magnetic resonance imaging
(MRI) of the liver is required to document the absence of tumor

- Blood urea nitrogen (BUN) no greater than 33 mg/dL OR Creatinine no greater than
1.8 mg/dL

- No other concurrent or prior malignancies within the past 5 years except:

- Cancer in situ

- Lobular carcinoma in situ of the breast

- Carcinoma in situ of the cervix

- Atypical melanocytic hyperplasia or Clark 1 melanoma in situ

- Basal or squamous cell skin cancer

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Clinical, radiological/laboratory, or pathological evidence of incompletely resected
melanoma or any distant metastatic disease

- Clinically palpable lymphadenopathy

- Evidence of organic brain syndrome or significant impairment of basal cognitive
function or any psychiatric disorder that would preclude study participation

- Other significant medical or surgical condition, or any medication or treatment
regimens, that would interfere with study participation

- Pregnant or nursing

- Other history of invasive melanoma

- Autoimmune disorders or conditions of immunosuppression

- History of active ischemic heart disease

- Cerebrovascular disease

- Congestive heart failure (New York Heart Association class III or IV heart disease)

- Prior or concurrent chemotherapy

- Prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or
other biologic response modifiers for melanoma

- Concurrent systemic corticosteroids including oral steroids (i.e., prednisone,
dexamethasone), topical steroid creams or ointments, or any steroid-containing
inhalers

- Prior or concurrent radiotherapy

- Other concurrent immunosuppressive medications

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
Terminated
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)
NSW
Recruitment hospital [1] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
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Alabama
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Arizona
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Arkansas
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California
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Connecticut
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Delaware
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Florida
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Georgia
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Michigan
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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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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Quebec
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Saskatchewan
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South Africa
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Pretoria

Funding & Sponsors
Primary sponsor type
Other
Name
ECOG-ACRIN Cancer Research Group
Address
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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
Southwest 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
NCIC Clinical Trials Group
Address [4] 0 0
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Other collaborator category [5] 0 0
Other
Name [5] 0 0
Children's Oncology Group
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known
whether treatment with interferon alfa is more effective than observation alone for stage II
or stage III melanoma that has been completely removed surgically.

PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how
well it works compared to observation only in treating patients with stage II or stage III
melanoma that has been completely removed by surgery.
Trial website
https://clinicaltrials.gov/show/NCT00003641
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sanjiv S. Agarwala, MD
Address 0 0
St. Luke's Cancer Network at St. Luke's Hospital
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