At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic melanoma
- ✓Measurable disease by CT/MRI (metastatic lesions) or physical exam (cutaneous lesions)
- ✓Surgery not feasible or inappropriate
- ✓ECOG performance status 0-1
- ✕Brain or meningeal metastases (current or history)
- ✕Ocular melanoma
- ✕Prior chemotherapy
- ✕Prior treatment with vaccines or biological response modifiers within 4 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of PI-88 With Dacarbazine in Patients With Metastatic Melanoma
In Brief
A Phase 2 clinical trial evaluating PI-88 and dacarbazine and dacarbazine or DTIC for Melanoma. Completed, enrolled 134 participants across 12 sites in 2 countries.
Detailed Summary
The aim of the study is to compare the safety and effectiveness of a new drug called PI-88, when used in combination with an approved chemotherapy drug called dacarbazine, in the treatment of metastatic melanoma. PI-88 blocks new blood vessel growth in tumours (starves it of nutrients) and dacarbazine stops the cancer cells from growing. The results from this study will be analysed to see if it is worthwhile for the two drugs to be tested in future studies involving larger numbers of melanoma patients.
Study Details
Timeline
Interventions
190 mg daily by subcutaneous injection for PI-88 and 1000 mg/m2 on day 1 of each 21 day cycle by intravenous infusion
intravenous infusion 1000 mg/m2 on day 1 of every 21 day cycle