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

Primary Purpose

Malignant Melanoma, Recurrent Melanoma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dacarbazine
Fotemustine
Interferon Alfa-2b
Sponsored by
National Cancer Institute, Naples
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Experimental

    Arm Label

    A1

    A2

    B1

    B2

    Arm Description

    combination chemotherapy without interferon

    combination chemotherapy with interferon

    single agent dacarbazine without interferon

    single agent dacarbazine plus interferon

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Treatment Related Toxicity
    worst grade CTC toxicity, for each cycle and overall, will be reported for each treatment arm

    Full Information

    First Posted
    May 13, 2011
    Last Updated
    March 15, 2023
    Sponsor
    National Cancer Institute, Naples
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01359956
    Brief Title
    Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma
    Acronym
    SICOG 0109
    Official Title
    Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    February 2011 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Cancer Institute, Naples

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malignant Melanoma, Recurrent Melanoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    269 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    A1
    Arm Type
    Experimental
    Arm Description
    combination chemotherapy without interferon
    Arm Title
    A2
    Arm Type
    Experimental
    Arm Description
    combination chemotherapy with interferon
    Arm Title
    B1
    Arm Type
    Active Comparator
    Arm Description
    single agent dacarbazine without interferon
    Arm Title
    B2
    Arm Type
    Experimental
    Arm Description
    single agent dacarbazine plus interferon
    Intervention Type
    Drug
    Intervention Name(s)
    Dacarbazine
    Intervention Description
    900 mg / m2 every 3 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Fotemustine
    Intervention Description
    100 mg / m2 every 3 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Interferon Alfa-2b
    Intervention Description
    5 M units every 3 weeks
    Primary Outcome Measure Information:
    Title
    Overall Survival (OS)
    Description
    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.
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Progression Free Survival (PFS)
    Description
    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.
    Time Frame
    12 months
    Title
    Overall Response Rate (ORR)
    Description
    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.
    Time Frame
    18 weeks from start of therapy
    Title
    Treatment Related Toxicity
    Description
    worst grade CTC toxicity, for each cycle and overall, will be reported for each treatment arm
    Time Frame
    at end of each 3 week cycle of therapy up to the discontinuation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paolo A Ascierto, M.D., Ph.D.
    Organizational Affiliation
    NCI Naples
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Antonio Daponte, M.D.
    Organizational Affiliation
    NCI Naples
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Simona Signoriello, M.D.
    Organizational Affiliation
    University of Campania "Luigi Vanvitelli"
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23402397
    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.
    Results Reference
    result

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

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