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Phase I/II and phase II studies of targeted gene delivery in vivo: intravenous Rexin-G for chemotherapy-resistant sarcoma and osteosarcoma.


ABSTRACT: Rexin-G, a pathotropic nanoparticle bearing a cytocidal cyclin G1 construct was tested in a phase I/II study for chemotherapy-resistant sarcomas and a phase II study for chemotherapy-resistant osteosarcoma. Twenty sarcoma patients and 22 osteosarcoma patients received escalating doses of Rexin-G intravenously from 8 x 10(11) to 24 x 10(11) colony forming units (cfu)/cycle. Treatment was continued if there was or=3 months and median OS, 6.9 months. These studies suggest that Rexin-G is safe, may help control tumor growth, and may possibly improve survival in chemotherapy-resistant sarcoma and osteosarcoma.

SUBMITTER: Chawla SP 

PROVIDER: S-EPMC2835268 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature

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Phase I/II and phase II studies of targeted gene delivery in vivo: intravenous Rexin-G for chemotherapy-resistant sarcoma and osteosarcoma.

Chawla Sant P SP   Chua Victoria S VS   Fernandez Lita L   Quon Doris D   Saralou Andreh A   Blackwelder William C WC   Hall Frederick L FL   Gordon Erlinda M EM  

Molecular therapy : the journal of the American Society of Gene Therapy 20090616 9


Rexin-G, a pathotropic nanoparticle bearing a cytocidal cyclin G1 construct was tested in a phase I/II study for chemotherapy-resistant sarcomas and a phase II study for chemotherapy-resistant osteosarcoma. Twenty sarcoma patients and 22 osteosarcoma patients received escalating doses of Rexin-G intravenously from 8 x 10(11) to 24 x 10(11) colony forming units (cfu)/cycle. Treatment was continued if there was <or= grade 1 toxicity. No dose-limiting toxicity (DLT) was observed, and no vector DNA  ...[more]

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