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Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Metastatic Melanoma

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Trial Information

Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy (CVD-Protocol) in the Second-Line Therapy of Distant Metastasized Malignant Melanoma


Inclusion Criteria:



- histological diagnosis of metastatic melanoma (stage IV)

- progressive disease after first-line chemotherapy or immuno-chemotherapy

- Karnofsky-index > 60%

- informed consent

Exclusion Criteria:

- Uvea melanoma

- another primary malignancy except basal cell carcinoma or cervical carcinoma in situ

- severe and/or uncontrolled medical disease (diabetes mellitus, cardiac insufficiency)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Principal Investigator

Jens Ulrich, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Dermatology, University Otto von Guericke, Leipziger Strasse 44, D-39120 Magdeburg, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

ADO-MM-PAL8

NCT ID:

NCT00226473

Start Date:

September 2001

Completion Date:

September 2005

Related Keywords:

  • Metastatic Melanoma
  • malignant Melanoma
  • Chemotherapy
  • Metastasis
  • standard palliative care
  • best supportive care
  • Melanoma
  • Neoplasm Metastasis

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