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Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study


Phase 3
18 Years
75 Years
Not Enrolling
Both
Malignant Melanoma, Recurrent Melanoma

Thank you

Trial Information

Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma: Phase III Study


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Paolo A Ascierto, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI Naples

Authority:

Italy: Ethics Committee

Study ID:

SICOG 0109

NCT ID:

NCT01359956

Start Date:

April 2002

Completion Date:

February 2011

Related Keywords:

  • Malignant Melanoma
  • Recurrent Melanoma
  • Melanoma

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