Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma

Phase 3

Completed

• Conditions: Malignant Melanoma; Recurrent Melanoma
• Interventions: Drug: Dacarbazine; Drug: Fotemustine; Drug: Interferon Alfa-2b

• Registration Number: NCT01359956
• Lead Sponsor: National Cancer Institute, Naples

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Status Verified: 2020-09
• Results First Submitted: 2020-09-09
• Results First Submitted QC: 2020-10-18
• Results First Posted: 2020-11-13
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
B1	Dacarbazine	single agent dacarbazine without interferon
A2	Fotemustine	combination chemotherapy with interferon
A1	Dacarbazine	combination chemotherapy without interferon
A1	Fotemustine	combination chemotherapy without interferon
A2	Dacarbazine	combination chemotherapy with interferon
B2	Dacarbazine	single agent dacarbazine plus interferon
B2	Interferon Alfa-2b	single agent dacarbazine plus interferon
A2	Interferon Alfa-2b	combination chemotherapy with interferon

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	12 months	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.
Treatment Related Toxicity	at end of each 3 week cycle of therapy up to the discontinuation	worst grade CTC toxicity, for each cycle and overall, will be reported for each treatment arm
Overall Response Rate (ORR)	18 weeks from start of therapy	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.