Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 66 of 506 for:    melanoma phase III

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01359956
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study
Study Start Date : April 2002
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. overall survival [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 12 months ]
  2. Response rate [ Time Frame: 18 weeks from start of therapy ]
  3. treatment related toxicity [ Time Frame: at end of each 3 week cycle of therapy ]
    worst grade CTC toxicity, for each cycle and overall, will be reported for each treatment arm



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359956


Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Layout table for investigator information
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. University of Campania "Luigi Vanvitelli"

Publications of Results:
Layout table for additonal information
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT01359956     History of Changes
Other Study ID Numbers: SICOG 0109
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Interferons
Interferon alpha-2
Fotemustine
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs