Condition category
Cancer
Date applied
19/10/2005
Date assigned
21/10/2005
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Adriano Paccagnella

ORCID ID

Contact details

Medical Oncology Unit
SS Giovanni e Paolo Hospital
Venezia
30100
Italy
adriano.paccagnella@ulss12.ve.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

IMI - Mel.A.

Study hypothesis

To verify if intensive intravenously IFN regimen is better than ECOG 1684 IFN regimen in patients with high risk melanoma (Stage III AJCC).

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

Treatment

Patient information sheet

Condition

Melanoma of cutaneous origin with regional lymph-node metastasis radically resected

Intervention

Dose-Dense/Dose-Intense arm: IFN alpha-2b 20 MU/m^2/day intravenously five days a week for four weeks, repeated for four times on weeks nine to 12, 17 to 20, 25 to 28

Standard arm: IFN alpha-2b 20 MU/m^2/day intravenously five days a week for four weeks followed by 10 MU/m^2 subcutaneously three times per week for 48 weeks.

Intervention type

Drug

Phase

Phase III

Drug names

Interferon alpha-2b

Primary outcome measures

Overall survival

Secondary outcome measures

1. Toxicity
2. Disease free survival

Overall trial start date

15/11/1998

Overall trial end date

15/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary melanoma of any tumour stage in presence of N1 regional lymph node metastases detected at elective or selective lymph node dissection with clinically not apparent regional lymph node metastases (designed CS1PS2, any TpN1M0)
2. Clinically apparent N1 regional lymph node involvement synchronous with primary melanoma of T1-4 (designed CS2PS2, any TcN1M0)
3. Regional lymph node recurrence at any interval after appropriate surgery for primary melanoma of any depth (designed CS2R, TxrN1M0)
4. ECOG performance status (PS) zero to one
5. Age 18 to 70
6. Absence of active medical or psychiatric troubles requiring medical or pharmacological interventions
7. Absence of thyroid or auto-immune pathology
8. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

328 patients

Participant exclusion criteria

1. Patients with non-cutaneous primary melanoma
2. Clinical or pathological evidence of not completely resected melanoma or of lymph-node metastases
3. Clinical history of progressed neoplasia, except for the in situ carcinoma of the cervix and of radically treated basal carcinomas
4. Patients requiring a continuous treatment with steroids, non-steroid antiinflammatory drugs or other inhibitors of the prostaglandins synthesis, antihistaminic (cimetidine, ranitidine, famotidine and nazatidine) or other known immunomodulators
5. Patients with history of (ventricular or supraventricular) heart rhythm troubles needing treatment, or congestive heart failure (class New York Heart Association [NYHA] more than two)
6. Patients with organic brain syndrome or significant deterioration of the basal cognitive function or with any psychiatric trouble which may hinder the complete participation in the protocol or which may be exacerbated from the IFN therapy (e.g. depression)
7. Patients previously submitted to adjuvant therapy, chemotherapy, immunotherapy, including any perfusion therapy before surgery

Recruitment start date

15/11/1998

Recruitment end date

15/11/2008

Locations

Countries of recruitment

Italy

Trial participating centre

Medical Oncology Unit
Venezia
30100
Italy

Sponsor information

Organisation

Italian Melanoma Intergroup - IMI (Italy)

Sponsor details

Istituto Oncologico Romagnolo
Corso Mazzini 65
Forlì
47100
Italy
+39 (0)543 35929
cor.epiclin@unipd.it

Sponsor type

Research organisation

Website

http://www.imi-online.it

Funders

Funder type

Research organisation

Funder name

Non-profit trial, partially supported by Italian Melanoma Intergroup (IMI)

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

2006 results on http://www.ncbi.nlm.nih.gov/pubmed/16504154

Publication citations

  1. Results

    Chiarion-Sileni V, Del Bianco P, Romanini A, Guida M, Paccagnella A, Dalla Palma M, Naglieri E, Ridolfi R, Silvestri B, Michiara M, De Salvo GL, Tolerability of intensified intravenous interferon alfa-2b versus the ECOG 1684 schedule as adjuvant therapy for stage III melanoma: a randomized phase III Italian Melanoma Inter-group trial (IMI - Mel.A.) [ISRCTN75125874]., BMC Cancer, 2006, 6, 44, doi: 10.1186/1471-2407-6-44.

Additional files

Editorial Notes