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High Dose Chemotherapy, Stem Cell Transplant, and Cellular Therapy in Recurrent/Refractory Brain Tumors
NCT00014573Phase 2
Key facts
- Status
- Completed
- Start
- Aug 1998
- Primary completion
- Oct 2004
- Countries
- 1
- Sponsor
- Barbara Ann Karmanos Cancer Institute
- Modality
- Cytokines & Interferons, Small Molecules, Cell Therapies
- Conditions
- brain tumor
01
Overview
Phase 2, open-label, single-arm trial of therapeutic autologous lymphocytes, aldesleukin, paclitaxel, cyclophosphamide, cisplatin and 3 more in brain tumor, sponsored by Barbara Ann Karmanos Cancer Institute. Primary endpoints: Effectiveness of the regimen up to 52 weeks, Safety and toxicity of the regimen up to 52 weeks and 1 more. Started Aug 1998; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Combination Therapy
Induction chemotherapy, vaccination, high-dose chemotherapy, stem cell transplantation, and cellular therapy.
03
Who it enrols
Patients aged 65 and under with recurrent or refractory primary high-grade brain tumors, adequate organ function, and recovered from prior therapies.
04
Endpoints
Primary
Effectiveness of the regimen
Safety and toxicity of the regimen
Quantitative cellular response
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