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

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
aldesleukin
recombinant interferon alfa
cisplatin
dacarbazine
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Landeskrankenanstalten - Salzburg
  • Institut Jules Bordet
  • Hopital Universitaire Erasme
  • Universitair Ziekenhuis Antwerpen
  • U.Z. Gasthuisberg
  • CHR de Besancon - Hopital Saint-Jacques
  • Centre Leon Berard
  • CHU Pitie-Salpetriere
  • Universitaetsklinikum Charite
  • Universitaetsklinikum Benjamin Franklin
  • Robert Roessle Klinik
  • Haematologisch-Onkologische Praxis Altona
  • Johannes Gutenberg University
  • III Medizinische Klinik Mannheim
  • Istituto Europeo Di Oncologia
  • University Medical Center Nijmegen
  • Rotterdam Cancer Institute
  • Instituto Portugues de Oncologia do Porto
  • Centre Hospitalier Universitaire Vaudois
  • Universitaetsspital
  • St. James's Hospital
  • Royal Marsden NHS Trust
  • Southend NHS Trust Hospital
  • Royal Bournemouth Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
June 29, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00002669
Brief Title
Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
Official Title
TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 1995 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
dacarbazine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Keilholz, MD
Organizational Affiliation
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Official's Role
Study Chair
Facility Information:
Facility Name
Landeskrankenanstalten - Salzburg
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels (Bruxelles)
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
CHR de Besancon - Hopital Saint-Jacques
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Universitaetsklinikum Charite
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Universitaetsklinikum Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Robert Roessle Klinik
City
Berlin
ZIP/Postal Code
D-13122
Country
Germany
Facility Name
Haematologisch-Onkologische Praxis Altona
City
Hamburg
ZIP/Postal Code
D-22765
Country
Germany
Facility Name
Johannes Gutenberg University
City
Mainz
ZIP/Postal Code
D-55101
Country
Germany
Facility Name
III Medizinische Klinik Mannheim
City
Mannheim
ZIP/Postal Code
D-68135
Country
Germany
Facility Name
Istituto Europeo Di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
Rotterdam Cancer Institute
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Instituto Portugues de Oncologia do Porto
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Universitaetsspital
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
St. James's Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Marsden NHS Trust
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Southend NHS Trust Hospital
City
Westcliff-On-Sea
State/Province
England
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19419855
Citation
Agarwala SS, Keilholz U, Gilles E, Bedikian AY, Wu J, Kay R, Stein CA, Itri LM, Suciu S, Eggermont AM. LDH correlation with survival in advanced melanoma from two large, randomised trials (Oblimersen GM301 and EORTC 18951). Eur J Cancer. 2009 Jul;45(10):1807-14. doi: 10.1016/j.ejca.2009.04.016. Epub 2009 May 4.
Results Reference
background
Citation
Keilholz U, Suciu S, Bedikian AY, et al.: LDH is a prognostic factor in stage IV melanoma patients (pts) but is a predictive factor only for bcl2 antisense treatment efficacy: re-analysis of GM301 and EORTC18951 randomized trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-8552, 485s, 2007.
Results Reference
background
PubMed Identifier
10685668
Citation
Keilholz U, Eggermont AM. The role of interleukin-2 in the management of stage IV melanoma: the EORTC melanoma cooperative group program. Cancer J Sci Am. 2000 Feb;6 Suppl 1:S99-103.
Results Reference
background
PubMed Identifier
17443000
Citation
Schmidt H, Suciu S, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, von der Maase H, Eggermont AM, Keilholz U; American Joint Committee on Cancer Stage IV Melanoma; EORTC 18951. Pretreatment levels of peripheral neutrophils and leukocytes as independent predictors of overall survival in patients with American Joint Committee on Cancer Stage IV Melanoma: results of the EORTC 18951 Biochemotherapy Trial. J Clin Oncol. 2007 Apr 20;25(12):1562-9. doi: 10.1200/JCO.2006.09.0274.
Results Reference
result
PubMed Identifier
17023156
Citation
Punt CJ, Suciu S, Gore MA, Koller J, Kruit WH, Thomas J, Patel P, Lienard D, Eggermont AM, Keilholz U. Chemoimmunotherapy with dacarbazine, cisplatin, interferon-alpha2b and interleukin-2 versus two cycles of dacarbazine followed by chemoimmunotherapy in patients with metastatic melanoma: a randomised phase II study of the European Organization for Research and Treatment of Cancer Melanoma Group. Eur J Cancer. 2006 Nov;42(17):2991-5. doi: 10.1016/j.ejca.2006.08.012. Epub 2006 Oct 4.
Results Reference
result
PubMed Identifier
16170182
Citation
Keilholz U, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, Thomas J, Proebstle TM, Schmittel A, Schadendorf D, Velu T, Negrier S, Kleeberg U, Lehman F, Suciu S, Eggermont AM. Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 2005 Sep 20;23(27):6747-55. doi: 10.1200/JCO.2005.03.202.
Results Reference
result
Citation
Keilholz U, Punt CJ, Gore M, et al.: Dacarbazine, cisplatin and interferon alpha with or without interleukin-2 in advanced melanoma: interim analysis of EORTC trial 18951. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A2043, 530a, 1999.
Results Reference
result

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

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