Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00002669

Collaborator

(none)

Enrollment

Locations

3.8

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.

Condition or Disease	Intervention/Treatment	Phase
Melanoma (Skin)	Biological: aldesleukin Biological: recombinant interferon alfa Drug: cisplatin Drug: dacarbazine	Phase 2

Detailed Description

OBJECTIVES:

Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2.
Assess toxicity, overall response rate, and response duration in these patients when treated with this regimen.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms.

Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses.

Patients are followed every 2 months for 6 months, then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL

Study Start Date :

Jun 1, 1995

Actual Primary Completion Date :

Aug 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed melanoma that is metastatic and unresectable
Measurable, progressive disease (by physical exam and/or noninvasive imaging)
No prior irradiation of indicator lesions
No CNS metastases (confirmed by CT or MRI)

PATIENT CHARACTERISTICS:

Age:

18 to 70

Performance status:

Karnofsky 60-100%

Life expectancy:

Greater than 3 months

Hematopoietic:

WBC at least 2,500/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

No serious hepatic disease

Renal:

Creatinine no greater than 1.65 mg/dL
No serious renal disease

Cardiovascular:

No serious cardiac disease

Pulmonary:

No serious pulmonary disease

Other:

No organ allograft
No autoimmune disease
No uncontrolled infection
No active peptic ulcer
No hyper or hypothyroidism
No requirement for corticosteroids
No second malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix
Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior immunotherapy with interleukin-2
No prior interferon alfa in combination with cisplatin or dacarbazine

Chemotherapy:

No prior chemotherapy with cisplatin in combination with dacarbazine
More than 3 months since prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

Prior radiotherapy allowed

Surgery:

Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Landeskrankenanstalten - Salzburg	Salzburg		Austria	A-5020
2	Institut Jules Bordet	Brussels (Bruxelles)		Belgium	1000
3	Hopital Universitaire Erasme	Brussels		Belgium	1070
4	Universitair Ziekenhuis Antwerpen	Edegem		Belgium	B-2650
5	U.Z. Gasthuisberg	Leuven		Belgium	B-3000
6	CHR de Besancon - Hopital Saint-Jacques	Besancon		France	25030
7	Centre Leon Berard	Lyon		France	69373
8	CHU Pitie-Salpetriere	Paris		France	75651
9	Universitaetsklinikum Charite	Berlin		Germany	D-10117
10	Universitaetsklinikum Benjamin Franklin	Berlin		Germany	D-12200
11	Robert Roessle Klinik	Berlin		Germany	D-13122
12	Haematologisch-Onkologische Praxis Altona	Hamburg		Germany	D-22765
13	Johannes Gutenberg University	Mainz		Germany	D-55101
14	III Medizinische Klinik Mannheim	Mannheim		Germany	D-68135
15	Istituto Europeo Di Oncologia	Milano		Italy	20141
16	University Medical Center Nijmegen	Nijmegen		Netherlands	NL-6500 HB
17	Rotterdam Cancer Institute	Rotterdam		Netherlands	3075 EA
18	Instituto Portugues de Oncologia do Porto	Porto		Portugal	4200
19	Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland	CH-1011
20	Universitaetsspital	Zurich		Switzerland	CH-8091
21	St. James's Hospital	Leeds	England	United Kingdom	LS9 7TF
22	Royal Marsden NHS Trust	London	England	United Kingdom	SW3 6JJ
23	Southend NHS Trust Hospital	Westcliff-On-Sea	England	United Kingdom
24	Royal Bournemouth Hospital	Bournemouth		United Kingdom	BH7 7DW