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

NCT01359956 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2023-04-11

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Paolo A Ascierto, M.D., Ph.D. · NCI Naples

  • Antonio Daponte, M.D. · NCI Naples

  • Simona Signoriello, M.D. · University of Campania Luigi Vanvitelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2011-02-28
Completion
2011-02-28

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01359956 on ClinicalTrials.gov