Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
28/06/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AIM HIGH

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Skin cancer

Intervention

Patients are randomised to one of two treatment arms:
1. Arm A: Interferon alpha-2a 3MU three times per week until recurrence, or for 2 years.
2. Arm B: No further treatment.

Intervention type

Drug

Phase

Not Specified

Drug names

Interferon Alpha-2a

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

22/12/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with histologically proven malignant melanoma and high risk of recurrent metastatic disease will be eligible for the present study. This will include patients with either:
a. Histologically proven metastatic melanoma in regional lymph nodes after therapeutic radical regional node dissection at initial presentation
b. Histologically proven metastatic melanoma in regional lymph nodes after therapeutic radical regional node dissection at subsequent presentation
c. Non-nodal superficial regional recurrence (local or in-transit disease)
d. Primary tumours 4 mm or more Breslow thickness without any other detectable focus of metastasis
2. Fit to receive interferon
3. Wound healed following surgery
4. Clinically disease-free
5. No history of other malignant disease, except previously cured early carcinoma of the cervix or skin
6. No previous biological therapy
7. Not on systemic steroids or other immunosuppressive therapy
8. Not pregnant, lactating or intending pregnancy during treatment
9. Less than 12 weeks since resection

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

674

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2000

Recruitment end date

22/12/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Roche Products Limited (UK)

Sponsor details

P.O. Box 8
Welwyn Garden City
Hertfordshire
AL7 3AY
United Kingdom

Sponsor type

Industry

Website

http://www.roche.com

Funders

Funder type

Industry

Funder name

Roche Products Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14665609

Publication citations

  1. Results

    Hancock BW, Wheatley K, Harris S, Ives N, Harrison G, Horsman JM, Middleton MR, Thatcher N, Lorigan PC, Marsden JR, Burrows L, Gore M, Adjuvant interferon in high-risk melanoma: the AIM HIGH Study--United Kingdom Coordinating Committee on Cancer Research randomized study of adjuvant low-dose extended-duration interferon Alfa-2a in high-risk resected malignant melanoma., J. Clin. Oncol., 2004, 22, 1, 53-61, doi: 10.1200/JCO.2004.03.185.

Additional files

Editorial Notes