Clinical trial NCT01359956: Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma
Official title: Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Melanoma
Recurrent Melanoma
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study evaluated two chemotherapy regimens with and without the addition of interferon in patients with advanced or recurrent melanoma.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 24 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 12 months
measure: Overall Response Rate (ORR)
timeFrame: 18 weeks from start of therapy
measure: Treatment Related Toxicity
timeFrame: at end of each 3 week cycle of therapy up to the discontinuation
Other outcomes:
Locations:
Study officials:
affiliation: NCI Naples
name: Paolo A Ascierto, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples
name: Antonio Daponte, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: Simona Signoriello, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.