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

NCT01359956 | Completed Phase 3 Results

• 1 other identifier: SICOG 0109
• Study Type: interventional
• Target: 269
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  12 months

• Overall Response Rate (ORR)

  18 weeks from start of therapy

• Treatment Related Toxicity

  at end of each 3 week cycle of therapy up to the discontinuation

Study Arms (4)

A1

EXPERIMENTAL

combination chemotherapy without interferon

Drug: Dacarbazine; Drug: Fotemustine

A2

EXPERIMENTAL

combination chemotherapy with interferon

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

B1

ACTIVE COMPARATOR

single agent dacarbazine without interferon

Drug: Dacarbazine

B2

EXPERIMENTAL

single agent dacarbazine plus interferon

Drug: Dacarbazine; Drug: Interferon Alfa-2b

Interventions

Dacarbazine DRUG

900 mg / m2 every 3 weeks

A1; A2; B1; B2

Fotemustine DRUG

100 mg / m2 every 3 weeks

A1; A2

Interferon Alfa-2b DRUG

5 M units every 3 weeks

A2; B2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Related Publications (1)

• 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.

  PMID: 23402397 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Dacarbazine; fotemustine; Interferon alpha-2

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Paolo A Ascierto, M.D., Ph.D
• Organization: NCI Naples

p.ascierto@istitutotumori.na.it

+39 081 5903431

Study Officials

• Paolo A Ascierto, M.D., Ph.D.

  NCI Naples

  PRINCIPAL INVESTIGATOR

• Antonio Daponte, M.D.

  NCI Naples

  PRINCIPAL INVESTIGATOR

• Simona Signoriello, M.D.

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: May 25, 2011
• Study Start: April 1, 2002
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 11, 2023
• Results First Posted: November 13, 2020

Record last verified: 2020-09