Randomised phase III clinical trial in patients radically operated for stage III melanoma (American Joint Committee on Cancer [AJCC]): comparison between Interferon (IFN) alpha-2b (sec Eastern Cooperative Oncology Group [ECOG] 1684) versus intensified Interferon alpha-2b
| ISRCTN | ISRCTN75125874 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75125874 |
| Protocol serial number | N/A |
| Sponsor | Italian Melanoma Intergroup - IMI (Italy) |
| Funder | Non-profit trial, partially supported by Italian Melanoma Intergroup (IMI) |
- Submission date
- 19/10/2005
- Registration date
- 21/10/2005
- Last edited
- 18/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Adriano Paccagnella
Scientific
Scientific
Medical Oncology Unit
SS Giovanni e Paolo Hospital
Venezia
30100
Italy
| adriano.paccagnella@ulss12.ve.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | IMI - Mel.A. |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Interferon alpha-2b |
| Primary outcome measure(s) |
Overall survival |
| Key secondary outcome measure(s) |
1. Toxicity |
| Completion date | 15/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 328 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/11/1998 |
| Date of final enrolment | 15/11/2008 |
Locations
Countries of recruitment
- Italy
Study participating centre
Medical Oncology Unit
Venezia
30100
Italy
30100
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/02/2006 | Yes | No |
