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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2011-02-28

Brief Summary

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

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Detailed Description

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Conditions

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Malignant Melanoma Recurrent Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A1

combination chemotherapy without interferon

Group Type EXPERIMENTAL

Dacarbazine

Intervention Type DRUG

900 mg / m2 every 3 weeks

Fotemustine

Intervention Type DRUG

100 mg / m2 every 3 weeks

A2

combination chemotherapy with interferon

Group Type EXPERIMENTAL

Dacarbazine

Intervention Type DRUG

900 mg / m2 every 3 weeks

Fotemustine

Intervention Type DRUG

100 mg / m2 every 3 weeks

Interferon Alfa-2b

Intervention Type DRUG

5 M units every 3 weeks

B1

single agent dacarbazine without interferon

Group Type ACTIVE_COMPARATOR

Dacarbazine

Intervention Type DRUG

900 mg / m2 every 3 weeks

B2

single agent dacarbazine plus interferon

Group Type EXPERIMENTAL

Dacarbazine

Intervention Type DRUG

900 mg / m2 every 3 weeks

Interferon Alfa-2b

Intervention Type DRUG

5 M units every 3 weeks

Interventions

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Dacarbazine

900 mg / m2 every 3 weeks

Intervention Type DRUG

Fotemustine

100 mg / m2 every 3 weeks

Intervention Type DRUG

Interferon Alfa-2b

5 M units every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No