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MelanomaPhase 2NCT00658437

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

A Phase 2 study testing CY-503 in people with Melanoma, run by Cytavis Biopharma GmbH at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Melanoma
What is being tested?
CY-503
Type of treatment
Injection or infusion
How many people
31 participants
Where
4 sitesGermany
Study dates
Apr 2008to May 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Haut Tumor Zentrum Charité

    Berlin, D-10117

  • Dermatologisches Zentrum Elbe-Klinikum Buxtehude

    Buxtehude, D-21603

  • Hautklinik Linden MH Hannover

    Hanover, D-30449

  • Universitäts-Hautklinik Kiel

    Kiel, D-24105

Other trials in Germany

About this study

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

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).

Conditions
Melanoma
Being tested
CY-503
Keywords
Melanoma, Stage IV, Phase II
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CY-503Drug

    solution for subcutaneous injection, 350 ng twice weekly

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor assessment by CT and MRT

    Measured: each 8 weeks

Secondary outcomes (2)

  1. Immunological response (e.g. measurement of cytokines in serum)

    Measured: each 4 weeks

  2. Assessment of quality of life using a standardized questionnaire

    Measured: each 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionAug 2009
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00658437
Sponsor's protocol ID
CY503C1
Other IDs
EudraCT no. 2007-000427-17
Status last verified
Aug 2009
First submitted
9 Apr 2008
Last updated
8 Jun 2011
Results posted
No
Data monitoring committee
No

Publications

  • Trefzer U, Gutzmer R, Wilhelm T, Schenck F, Kahler KC, Jacobi V, Witthohn K, Lentzen H, Mohr P. Treatment of unresectable stage IV metastatic melanoma with aviscumine after anti-neoplastic treatment failure: a phase II, multi-centre study. J Immunother Cancer. 2014 Aug 19;2:27. doi: 10.1186/s40425-014-0027-z. eCollection 2014.

    PubMed 25324973

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CY-503 in people with Melanoma, run by Cytavis Biopharma GmbH at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor assessment by CT and MRT (time frame: each 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00658437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.

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