Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma (SICOG 0109)

National Cancer Institute, Naples

Status and phase: Completed; Phase 3

Conditions: Malignant Melanoma; Recurrent Melanoma

Treatments: Drug: Interferon Alfa-2b; Drug: Dacarbazine; Drug: Fotemustine

Study type: Interventional

Funder types: Other

Identifiers

NCT01359956

SICOG 0109

Details and patient eligibility

About

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

Enrollment: 269 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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269 participants in 4 patient groups

A1

Experimental group

Description:

combination chemotherapy without interferon

Treatment:

Drug: Fotemustine

Drug: Dacarbazine

A2

Experimental group

Description:

combination chemotherapy with interferon

Treatment:

Drug: Fotemustine

Drug: Dacarbazine

Drug: Interferon Alfa-2b

B1

Active Comparator group

Description:

single agent dacarbazine without interferon

Treatment:

Drug: Dacarbazine

B2

Experimental group

Description:

single agent dacarbazine plus interferon

Treatment:

Drug: Dacarbazine

Drug: Interferon Alfa-2b