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Status:

UNKNOWN

Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to...

Detailed Description

OBJECTIVES: Primary * Compare the objective response rate (complete and partial response) in patients with unresectable stage III or stage IV M1a cutaneous melanoma immunized with vaccine comprising...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed cutaneous melanoma
  • Unresectable stage III OR stage IV M1a disease
  • Documented progressive disease within the past 12 weeks
  • Measurable disease
  • Skin, soft tissue, or lymph node metastasis allowed provided the disease is not amenable to curative treatment with surgery
  • Tumor must express the MAGE-3 gene by reverse transcription polymerase chain reaction analysis (more than 1% of the positive MAGE-3 control included in the assay)
  • No visceral metastases within the past 56 days by imaging
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Hemoglobin ≥ lower limit of normal (LLN)
  • WBC ≥ LLN
  • Lymphocyte count ≥ LLN
  • Platelet count ≥ LLN
  • No bleeding disorders
  • Hepatic
  • Bilirubin ≤ upper limit of normal (ULN)
  • Lactic dehydrogenase ≤ ULN
  • AST and ALT ≤ 2 times ULN
  • PT and aPTT normal
  • Hepatitis B surface antigen negative (antibody test may be positive)
  • Hepatitis C antibody negative
  • Renal
  • Creatinine ≤ ULN
  • Cardiovascular
  • No clinically significant heart disease (CTC grade III or IV)
  • Immunologic
  • No autoimmune disease (vitiligo allowed)
  • No anti-nuclear antibody titer ≥ 1/320 OR equal to 1/160 AND auto-antibodies directed against specific auto-antigens
  • No immunodeficiency
  • No active infection requiring antibiotic therapy
  • HIV negative
  • Other
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No other malignancy within the past 5 years except surgically cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No other serious acute or chronic illness requiring concurrent medications
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 8 weeks since prior adjuvant vaccine therapy
  • No prior vaccine therapy containing a MAGE-3 antigen
  • No prior vaccine therapy for metastatic melanoma
  • No concurrent immunomodulating agents (e.g., BCG)
  • Chemotherapy
  • No prior systemic chemotherapy
  • No concurrent chemotherapy
  • Endocrine therapy
  • No concurrent corticosteroids
  • Concurrent prednisone or equivalent allowed provided the dose is ≤ 40 mg/day and treatment duration is for no more than 3 weeks
  • Concurrent inhaled and topical steroids are allowed
  • Radiotherapy
  • No prior radiotherapy to the spleen
  • No concurrent radiotherapy to \> 20% of all existing lesions (i.e., target lesions, non-target lesions, and nonmeasurable lesions)
  • Concurrent local low-dose (≤ 20 Grays) radiotherapy allowed
  • Surgery
  • Recovered from prior surgery or biopsy
  • No prior organ allograft
  • No prior splenectomy
  • Concurrent surgery to a limited number of lesions allowed for patients with a complete response, partial response, or stable disease after at least 3 courses of study therapy
  • Other
  • No prior systemic anticancer therapy
  • More than 4 weeks since prior isolated limb perfusion therapy
  • No other concurrent anticancer therapy
  • No other concurrent immunosuppressive agents

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    165 Patients enrolled

    Trial Details

    Trial ID

    NCT00086866

    Start Date

    May 1 2004

    Last Update

    February 10 2015

    Active Locations (21)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (21 locations)

    1

    Institut Jules Bordet

    Brussels, Belgium, 1000

    2

    Hopital Universitaire Erasme

    Brussels, Belgium, 1070

    3

    Clinique Sainte-Marguerite

    Hyères, France, 83400

    4

    Centre Hospitalier Regional et Universitaire de Lille

    Lille, France, 59037