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CY503 for the Treatment of Malignant Melanoma Stage IV After Failure of Prior Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00658437
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Cytavis Biopharma GmbH

Brief Summary:
The trial is designed as a phase II evaluation of the effect of CY-503 on progression free survival (PFS) in patients with stage IV malignant melanoma after failure of prior therapy. The aim of the study is at least a rate of 25% (PFS >/= 3 months).

Condition or disease Intervention/treatment Phase
Melanoma Drug: CY-503 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Study to Test Progression-free and Overall Survival of CY-503 in the Treatment of Patients With Unresectable Stage IV Metastatic Melanoma After Antineoplastic Treatment Failure
Study Start Date : April 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma


Intervention Details:
  • Drug: CY-503
    solution for subcutaneous injection, 350 ng twice weekly


Primary Outcome Measures :
  1. Tumor assessment by CT and MRT [ Time Frame: each 8 weeks ]

Secondary Outcome Measures :
  1. Immunological response (e.g. measurement of cytokines in serum) [ Time Frame: each 4 weeks ]
  2. Assessment of quality of life using a standardized questionnaire [ Time Frame: each 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed, unresectable, Stage IV metastatic melanoma
  • Failure of prior chemotherapy and / or immunotherapy based regimen
  • Measurable disease (based on RECIST criteria)
  • Males and females of at least 18 years of age
  • Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative pregnancy test within 3 days prior to randomization; and men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
  • Life expectancy of at least 3 months
  • WBC ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥100,000/mm3
  • Bilirubin ≤ 1.5 mg/dL (25.65 μmol/L) (unless due to Gilbert's syndrome in which case the bilirubin should be ≤3.5 mg/dL (59.86 μmol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN); hepatic alkaline phosphatase ≤ 3.0 × ULN
  • LDH ≤ 2.5 upper limit of normal (ULN)
  • Serum creatinine ≤ 1.5 mg/dL (132.60 μmol/L), proteinuria < 2.0 g/24 hr urine
  • Patients who have had prior treatment with adjuvant or palliative immunotherapy are eligible provided that therapy ended at least 1 month prior to randomization and all treatment-related toxicities have resolved
  • Patients with bone metastasis should be evaluated by the investigator and prior treatment should be finished at least 1 month prior to randomization
  • Prior radiotherapy (for palliative care only) is allowed provided there is measurable/evaluable disease outside of the radiation field and all radiation-related toxicities have resolved; if there is only one measurable lesion it may not have been irradiated unless subsequent progression has been documented
  • Patients who had prior major surgery are eligible if at least 4 weeks have passed since their surgery and all surgical wounds have healed prior to randomization and at least one measurable tumor is present
  • All toxicities related to prior adjuvant therapy must have resolved
  • Written informed consent

Exclusion Criteria:

  • Pregnancy or nursing
  • Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
  • Current or planned participation in a research protocol
  • Received an investigational agent within 4 weeks prior to randomization
  • Brain metastases or primary brain tumors, symptomatic pleural effusion or ascites requiring paracentesis
  • Ocular melanoma
  • History of prior malignancies within the past 5 years other than non-melanomatous skin cancers that have been controlled, carcinoma in situ of the cervix, T1a or b prostate cancer noted incidentally during a transurethral resection of prostate (TURP) with prostate-specific antigen (PSA) values within normal limits since TURP, or superficial bladder cancer
  • Any evidence of or history elicited by the investigator of symptomatic cerebrovascular events within 6 months prior to randomization; or any history or evidence of pulmonary embolism or thrombophlebitis requiring anticoagulant therapy
  • Any current evidence of hematemesis, melena, hematochezia, or gross hematuria
  • Elective surgery planned during the study period through 30 days after the last dose of CY-503
  • History of hypersensitivity to previously administered mistletoe
  • Prior therapy with mistletoe
  • History of primary immunodeficiency
  • Known human immunodeficiency virus (HIV) or known active viral hepatic infections
  • Prior treatment with CY-503
  • A general medical or psychological condition or behaviour in the opinion of the investigator, might not permit the patient to complete the study or sign the informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658437


Locations
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Germany
Haut Tumor Zentrum Charité
Berlin, Germany, D-10117
Dermatologisches Zentrum Elbe-Klinikum Buxtehude
Buxtehude, Germany, D-21603
Hautklinik Linden MH Hannover
Hannover, Germany, D-30449
Universitäts-Hautklinik Kiel
Kiel, Germany, D-24105
Sponsors and Collaborators
Cytavis Biopharma GmbH
Investigators
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Principal Investigator: Peter Mohr, MD Elbe Klinikum Buxtehude, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cytavis Biopharma GmbH, Industry
ClinicalTrials.gov Identifier: NCT00658437     History of Changes
Other Study ID Numbers: CY503C1
EudraCT no. 2007-000427-17
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: August 2009
Keywords provided by Cytavis Biopharma GmbH:
Melanoma, Stage IV, Phase II
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas