PegIntron Versus IntronA in CMAJCC Stage II (EADO 2001/CMII Trial)

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221702
First received: September 13, 2005
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

Melanoma with a tumor thickness >= 1.5mm without clinically detectable nodes represents an increasing population with relapse rate of more than 50%. Adjuvant therapy with low doses of IFN alpha can provide a benefit in this group. However, the impact of low dose IFN alpha is not sustained after the treatment period. A longer treatment may prolong the benefit and thus have a more clear-cut impact on disease-free and overall survival. The tolerance and the impact on quality of life are limiting factors in a group of patients whose individual course is not necessarily poor. PegIntron may be better tolerated than instant release interferon, and thus make this treatment more acceptable in terms of toxicity and quality of life. Thus treatment schedule with PegIntron is not expected to increase the cost of standard care significantly.


Condition Intervention Phase
Melanoma
Neoplasm Metastasis
Drug: PegIntron
Drug: intron A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Multicenter Phase III Trial Comparing Adjuvant Treatment With PegIntron Over 36 Months Versus Reference Treatment With IntronA Over 18 Months in Cutaneous Melanoma Patients AJCC Stage II (>=1.5 mm Clinically Node Negative)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • disease-free survival time [ Time Frame: 5-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to distant metastasis [ Time Frame: the time from the inclusion to the first documentation of any distant metastasis ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: the time from the inclusion to the date of death regardless of the specific cause ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: for 36 months ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 898
Study Start Date: June 2003
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Peg Intron 100 mcg SC/week for 36 months
Drug: PegIntron
100 mcg SC/week for 36 months
Active Comparator: B
Intron A 3 X 3 MIU, weekly, sc, for 18 months
Drug: intron A
3mui TIWW SC for 18 months

Detailed Description:

Study design and primary objective

This is an European multicenter, open label, prospective randomized phase III trial evaluating the efficacy of long-term maintenance therapy of two therapy options, IntronA for 18 months versus PegIntron for 36 months, administered in an adjuvant setting after the local excision of an intermediate risk cutaneous melanoma.

Eligibility criteria

Intermediate risk melanoma is defined by the following criteria: (1) a tumor thickness >= 1,5mm and (2) the absence of regional nodal macrometastases, as assessed either by clinical examination or, if sentinel lymph node biopsy (SLNB) or elective node dissection (ELND) are performed, by the absence of macroscopic evidence of disease. Patients with evidence of nodal micrometastasis by SLNB or ELND are eligible. The choice of performing sentinel node dissection will be left to the decision of each center, on condition to concern all consecutive patients and that all surgical procedures are completed before randomization of the patients . The centers have to inform their respective national study center if they perform SLNB or ELND and also if they change their surgical procedure.

Study treatments

  • Arm A : PegIntron 100 mcg SC/week for 36 months
  • Arm B : IntronA 3miu TIWW SC for 18 months

Endpoints

The primary endpoint of the study will be the time to any recurrence (local recurrence, satellite or in transit metastasis, regional node metastasis or distant metastasis) or death, whatever the cause. The primary comparison between the two arms will use the 5-year disease-free survival time. Secondary endpoints are time to distant metastasis , overall survival, toxicity and quality of life.

Therapy with either PegIntron or IntronA will continue as scheduled unless there is evidence of disease progression (whether local or distant recurrence), severe toxicity, or the subject requests that therapy be discontinued. All patients will be followed for disease-free-survival and overall survival until the end of the trial.

Sample size and analysis

The calculated sample size is 1190 patients to be enrolled over a 5 years period; this sample size is inclusive of an expected lost to follow up not more than 10% during the course of the trial. The randomization procedure will be stratified according to centers and to sentinel node biopsy. The primary analysis will be performed under the intent to treat principle.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven cutaneous melanoma
  • Tumour thickness >= 1.5 mm (Breslow staging)
  • Absence of clinically detectable regional node metastasis, no evidence of distant metastasis
  • Informed consent form signed

Exclusion Criteria:

  • Any prior chemo-, immuno-, hormonal or radiation therapy
  • Macroscopic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221702

Locations
France
APHM, dermatology
Marseille, France, 13274
Sponsors and Collaborators
University Hospital, Bordeaux
Schering-Plough
Investigators
Principal Investigator: Jean - Jacques GROB, Professor University Hospital, Marseille
Study Chair: Geneviève Chêne, Professor University Hospital, Bordeaux
  More Information

No publications provided by University Hospital, Bordeaux

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean Pierre LEROY/ Clinical Research and innovation Director, University Hospital Bordeaux
ClinicalTrials.gov Identifier: NCT00221702     History of Changes
Other Study ID Numbers: 9267-01, 2001-034
Study First Received: September 13, 2005
Last Updated: October 12, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Austria: Federal Ministry for Health and Women

Keywords provided by University Hospital, Bordeaux:
Melanoma
Neoplasm metastasis
Interferon alfa-2b
Adjuvants
Randomized clinical trial
Disease-free survival time
Safety
Drug toxicity
Quality of life

Additional relevant MeSH terms:
Neoplasms
Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Reaferon
Interferon Alfa-2b
Peginterferon alfa-2b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Alcohol Deterrents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 21, 2014