A Study Comparing the Effects on Melanoma With High Dose IFN Alone vs Cisplatin Velban DTIC IL2 IFN and G CSF
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- STATUS
- Recruiting
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- participants needed
- 410
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- sponsor
- Hackensack University Medical Center
Summary
What is the overall survival and disease-free survival between patients with high risk melanoma who recieve high dose interferon Alphe 2b versus Cisplatin, Vinblastine, DTIC plus IL-2 and Interferon. Also what toxicities of these two regimens in the patient population.
Description
To compare the overall survival and disease-free survival between patients with high risk melanoma who recieve high dose interferon Alphe 2b versus Cisplatin, Vinblastine, DTIC plus IL-2 and Interferon. To evaluate the toxicities of these two regimens in the patient population. To investigate the predictive value for disease (OS and DFS) and explore the relationship with patient clinical characteistics (# of involved lymph nodes,ulcerated primary, extracapsular extension)of minimal residual disease(MRD)by RT-PCR in the peripheral blood at baseline. To investigate the effects of treatment (high dose IFN vs biochemotherapy) on the status of mRD in peripheral blood at 12 and 52 weeks. To explore the relationship between MRD status at 12 weeks and 52 weeks, with subsequesnt overall survival.
Details
| Condition | Melanoma |
|---|---|
| Treatment | Cisplatin,Dacarbazine, Filgrastim, IFN alpha2b, IL-2,Velban |
| Clinical Study Identifier | NCT00546416 |
| Sponsor | Hackensack University Medical Center |
| Last Modified on | 7 November 2020 |
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