Phase I trial of multiple cycles of high-dose chemotherapy supported by autologous peripheral-blood stem cells

Russell J. Schilder, Steven Johnson, James Gallo, Scott Kindsfather, Barbara Rogers, Michael A. Bookman, Michael M. Millenson, Matthew Boente, Norman Rosenblum, Samuel Litwin, Robert F. Ozols

Research output: Contribution to journalArticlepeer-review

20 Scopus citations


Purpose: To determine the safety and feasibility of delivering multiple cycles of front-line high-dose carboplatin and paclitaxel with hematapoietic peripheral-blood stem cell (PBSC) support. Patients and Methods: Patients were required to have a malignant solid tumor for which they had received no prior chemotherapy. Mobilization of PBSC was achieved with cyclophosphamide, etoposide, and granulocyte-macrophage colony-stimulating factor (GM-CSF). After one cycle of conventional-dose carboplatin and cyclophosphamide with GM-CSF, patients received multiple cycles of high-dose carboplatin (area under the concentration-time curve [AUC], 12 to 20) and paclitaxel (250 mg/m2) with PBSC and GM-CSF repeated every 28 days. Results: Twenty-four of 28 patients were assessable for toxicity and clinical outcome. Dose-limiting toxicities were dehydration, diarrhea, and electrolyte imbalances. The maximum-tolerated dose of carboplatin was AUC 16 (equivalent to a median of 1,189 mg/m2). The relationship of target AUC to measured AUC was linear (r2 = .29; P = .0011). The overall response rate was 96%, with a complete clinical response rate of 67%. The median time to progression from the first PBSC reinfusion was 49.5 weeks (range, 8 to 156+ weeks). Conclusion: Multiple cycles of high-dose carboplatin (AUC 16) and paclitaxel (250 mg/m2) can be safely administered with GM-CSF and PBSC support. Although this regimen is safe, feasible, and active, the use of multiple cycles of high-dose chemotherapy as front-line treatment remains experimental and should only be used in the context of a clinical trial.

Original languageEnglish
Pages (from-to)2198-2207
Number of pages10
JournalJournal of Clinical Oncology
Issue number7
StatePublished - Jul 1999
Externally publishedYes


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