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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT01359956
First received: May 13, 2011
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Malignant Melanoma
Recurrent Melanoma
Drug: Dacarbazine
Drug: Fotemustine
Drug: Interferon Alfa-2b
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: 18 weeks from start of therapy ] [ Designated as safety issue: No ]
  • treatment related toxicity [ Time Frame: at end of each 3 week cycle of therapy ] [ Designated as safety issue: No ]
    worst grade CTC toxicity, for each cycle and overall, will be reported for each treatment arm


Enrollment: 269
Study Start Date: April 2002
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1
combination chemotherapy without interferon
Drug: Dacarbazine
900 mg / m2 every 3 weeks
Drug: Fotemustine
100 mg / m2 every 3 weeks
Experimental: A2
combination chemotherapy with interferon
Drug: Dacarbazine
900 mg / m2 every 3 weeks
Drug: Fotemustine
100 mg / m2 every 3 weeks
Drug: Interferon Alfa-2b
5 M units every 3 weeks
Active Comparator: B1
single agent dacarbazine without interferon
Drug: Dacarbazine
900 mg / m2 every 3 weeks
Experimental: B2
single agent dacarbazine plus interferon
Drug: Dacarbazine
900 mg / m2 every 3 weeks
Drug: Interferon Alfa-2b
5 M units every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359956

Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: Paolo A Ascierto, M.D., Ph.D. NCI Naples
Principal Investigator: Antonio Daponte, M.D. NCI Naples
Principal Investigator: Simona Signoriello, M.D. Second University of Naples
  More Information

Publications:
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01359956     History of Changes
Other Study ID Numbers: SICOG 0109
Study First Received: May 13, 2011
Last Updated: April 1, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Fotemustine
Interferon-alpha
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014