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

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ClinicalTrials.gov Identifier: NCT00002669
Recruitment Status : Completed
First Posted : April 11, 2003
Last Update Posted : July 2, 2012
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE June 2, 2000
First Posted Date  ICMJE April 11, 2003
Last Update Posted Date July 2, 2012
Study Start Date  ICMJE June 1995
Actual Primary Completion Date August 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00002669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
Official Title  ICMJE TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Melanoma (Skin)
Intervention  ICMJE
  • Biological: aldesleukin
  • Biological: recombinant interferon alfa
  • Drug: cisplatin
  • Drug: dacarbazine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February¬†8,¬†2007)
90
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Italy,   Netherlands,   Portugal,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002669
Other Study ID Numbers  ICMJE EORTC-18951
EORTC-18951
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ulrich Keilholz, MD Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP