Malignant MelanomaPhase 3SICOG 0109NCT01359956
Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma
A Phase 3 study testing Dacarbazine, Fotemustine and Interferon Alfa-2b in people with Malignant Melanoma and Recurrent Melanoma, run by National Cancer Institute, Naples.
Trial summary
This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Melanoma, Recurrent Melanoma
- What is being tested?
- Dacarbazine, Fotemustine and Interferon Alfa-2b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Feb 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of malignant melanoma in advanced stage or recurrent after surgery, and not amenable to further surgery or local therapy.
- Presence of measurable disease
- Age > or = 18 years and < or = 75 years
- Performance status (ECOG) 0 - 2 (Appendix 2)
- Life expectancy ³ 3 months
- Adequate bone marrow function (ANC ³ 2,000/mmc; PTL ³ 100,000/mmc; Hb ³ 10 gr/dl), normal liver and renal function (bilirubin < 1.25 x N, creatinine < 1.25 x N, SGOT, SGPT < 3 times upper normal limit of testing laboratory.
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- Written, informed consent prior to study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- Prior surgery > 3 weeks from initiating .
- If palliative radiation is needed, in case of non target lesions, it must be given prior to initiating chemotherapy. If palliative radiation is required during the study the patient should be permanently discontinued from further treatment.
- Adequate contraceptive measures during study participation for sexually active patients of child bearing potential must implement.
Who cannot join
- Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.
- Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed)
- Known HIV disease.
- Concurrent treatment with other experimental drugs.
- Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy
- Pregnant or lactating females Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.
- Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed) Known HIV disease. Concurrent treatment with other experimental drugs. Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy
About this study
Official title: Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study
This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.
- Conditions
- Malignant Melanoma, Recurrent Melanoma
- Being tested
- Dacarbazine, Fotemustine, Interferon Alfa-2b
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DacarbazineDrug
900 mg / m2 every 3 weeks
FotemustineDrug
100 mg / m2 every 3 weeks
Interferon Alfa-2bDrug
5 M units every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | combination chemotherapy without interferon Receives: Drug: Dacarbazine; Drug: Fotemustine |
| A2 | Experimental | combination chemotherapy with interferon Receives: Drug: Dacarbazine; Drug: Fotemustine; Drug: Interferon Alfa-2b |
| B1 | Active comparator | single agent dacarbazine without interferon Receives: Drug: Dacarbazine |
| B2 | Experimental | single agent dacarbazine plus interferon Receives: Drug: Dacarbazine; Drug: Interferon Alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall Survival was defined as the time from the date of randomisation to the date of death from any cause or the date of last follow-up for living patients.
OS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two - sided log - rank test.
Measured: 24 months
Secondary outcomes (3)
Progression Free Survival (PFS)
Progression Free Survival (PFS) was defined as the time from the date of randomisation to the date of progression of disease or death from any cause, whichever occurred first, or date of last follow-up for patients without progression and alive at the end of the study.
PFS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two-sided log-rank test.
Measured: 12 months
Overall Response Rate (ORR)
Overall Response Rate (ORR) included Complete Response (CR) and Partial Response (PR).
Complete Response (CR) was defined as disappearance of all symptoms and signs of all measurable disease, lasting for at least four weeks, without appearance of new lesions.
Partial Response (PR) was defined as a > 50% reduction in the sum of the products of the perpendicular diameters of all measurable lesions, lasting for at least four weeks, without appearance of new lesions or enlargement of existing lesions.
Measured: 18 weeks from start of therapy
Treatment Related Toxicity
worst grade CTC toxicity, for each cycle and overall, will be reported for each treatment arm
Measured: at end of each 3 week cycle of therapy up to the discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startApr 2002
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo A Ascierto, M.D., Ph.D., Principal investigator, NCI NaplesAntonio Daponte, M.D., Principal investigator, NCI NaplesSimona Signoriello, M.D., Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359956
- Sponsor's protocol ID
- SICOG 0109
- Acronym
- SICOG 0109
- Status last verified
- Sep 2020
- First submitted
- 13 May 2011
- Last updated
- 11 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Daponte A, Signoriello S, Maiorino L, Massidda B, Simeone E, Grimaldi AM, Caraco C, Palmieri G, Cossu A, Botti G, Petrillo A, Lastoria S, Cavalcanti E, Aprea P, Mozzillo N, Gallo C, Comella G, Ascierto PA; Southern Italy Cooperative Oncology Group (SICOG). Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-alpha in advanced malignant melanoma. J Transl Med. 2013 Feb 13;11:38. doi: 10.1186/1479-5876-11-38.
PubMed 23402397
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study
- ClinicalTrials.gov ID
- NCT01359956
- Acronym / sponsor ID
- SICOG 0109 / SICOG 0109
- Conditions
- Malignant Melanoma, Recurrent Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 25 May 2011 (estimated)
- Results
- Posted 13 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: Dacarbazine, Drug: Fotemustinecombination chemotherapy without interferon |
| A2 | Experimental | Drug: Dacarbazine, Drug: Fotemustine, Drug: Interferon Alfa-2bcombination chemotherapy with interferon |
| B1 | Active comparator | Drug: Dacarbazinesingle agent dacarbazine without interferon |
| B2 | Experimental | Drug: Dacarbazine, Drug: Interferon Alfa-2bsingle agent dacarbazine plus interferon |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed diagnosis of malignant melanoma in advanced stage or recurrent after surgery, and not amenable to further surgery or local therapy.
- Presence of measurable disease
- Age > or = 18 years and < or = 75 years
- Performance status (ECOG) 0 - 2 (Appendix 2)
- Life expectancy ³ 3 months
Key exclusion criteria (7 listed)
- Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin.
- Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed)
- Known HIV disease.
- Concurrent treatment with other experimental drugs.
- Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dacarbazine900 mg / m2 every 3 weeks | Drug | A1, A2, B1, B2 |
| Fotemustine100 mg / m2 every 3 weeks | Drug | A1, A2 |
| Interferon Alfa-2b5 M units every 3 weeks | Drug | A2, B2 |
Primary outcome
Overall Survival (OS)
Time frame: 24 months
Overall Survival was defined as the time from the date of randomisation to the date of death from any cause or the date of last follow-up for living patients. OS curves were estimated with the Kaplan - Meier (K-M) method and treatments were compared with a two - sided log - rank test.
3 secondary outcomes
Progression Free Survival (PFS)
Time frame: 12 months
Overall Response Rate (ORR)
Time frame: 18 weeks from start of therapy
Treatment Related Toxicity
Time frame: at end of each 3 week cycle of therapy up to the discontinuation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23402397Daponte A, Signoriello S, Maiorino L, Massidda B, Simeone E, Grimaldi AM, Caraco C, Palmieri G, Cossu A, Botti G, Petrillo A, Lastoria S, Cavalcanti E, Aprea P, Mozzillo N, Gallo C, Comella G, Ascierto PA; Southern Italy Cooperative Oncology Group (SICOG). Phase III randomized study of fotemustine and dacarbazine versus dacarbazine with or without interferon-alpha in advanced malignant melanoma. J Transl Med. 2013 Feb 13;11:38. doi: 10.1186/1479-5876-11-38.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo A Ascierto, M.D., Ph.D. principal investigator
NCI Naples
Antonio Daponte, M.D. principal investigator
NCI Naples
Simona Signoriello, M.D. principal investigator
University of Campania Luigi Vanvitelli
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dacarbazine, Fotemustine and Interferon Alfa-2b in people with Malignant Melanoma and Recurrent Melanoma, run by National Cancer Institute, Naples.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01359956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.