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Standard Palliative Care Versus Standard Palliative Care Plus Polychemotherapy in Metastasized Malignant Melanoma

D

Dermatologic Cooperative Oncology Group

Status and phase

Unknown
Phase 4

Conditions

Metastatic Melanoma

Treatments

Drug: Cisplatin, Vindesine, Dacarbazine (drugs)

Study type

Interventional

Funder types

Other

Identifiers

NCT00226473
ADO-MM-PAL8

Details and patient eligibility

About

The purpose of this multicenter study is to examine whether the proposed randomized treatment regime results in a significantly longer survival time and higher quality of life than any additionally applied multiple chemotherapy according to the CVD- scheme. So far neither established treatment regimes nor reliable data exist for the second-line chemotherapy of metastatic malignant melanoma. Patients are therefore mostly treated with single or multiple chemotherapeutics or/and immunomodulatory therapeutics. These regimes however imply often not only a higher toxicity but show rarely a response rate higher than 10%.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

13

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Central trial contact

Jens Ulrich, MD

Data sourced from clinicaltrials.gov

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