Abstract | PURPOSE: EXPERIMENTAL DESIGN: Nine patients with recurrent or metastatic head and neck squamous cell carcinoma were treated at radiation dose levels of 1.0, 1.5, and 2.0 GBq/m2. Before RIT, G-CSF (10 microg/kg/day) was administered s.c. at home during 5 days. On day 6, just before administration of 186Relabeled cMAb U36, 1 liter of whole blood was harvested and kept unprocessed at 4 degrees C until reinfusion after 72 h. Blood samples were taken for analysis of pharmacokinetics and bone marrow dosimetry. Patients were evaluated for myelotoxicity and tumor response. RESULTS: Blood harvesting, RIT, and reinfusion of whole blood were well tolerated by all patients. G-CSF stimulation resulted in a mean of 0.41 x 10(6) CD34+ cells/kg (range, 0.15-0.83 x 10(6) CD34+cells/kg) and a mean committed colony-forming units granulocyte macrophage count of 5.62 x 10(4)/kg (range, 0.62-13.37 x 10(4)/kg). The mean biological half-life of 186Relabeled cMAb U36 in blood was 72.6 +/- 16.0 h, and bone marrow doses ranged from 2.1 to 2.8 Gy at the highest dose level. Myelotoxicity exceeding grade 3 was not observed. Stable disease was observed in five of nine patients, ranging from 3 to 5 months, and was still ongoing in one of these patients. CONCLUSIONS: This study indicates that a doubling of the maximum tolerated activity and bone marrow dose of 186Relabeled cMAb U36 can be achieved using reinfusion of G-CSF-stimulated unprocessed whole blood.
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Authors | David R Colnot, Gert J Ossenkoppele, Jan C Roos, Jasper J Quak, Remco de Bree, Pontus K Börjesson, Peter C Huijgens, Gordon B Snow, Guus A M S van Dongen |
Journal | Clinical cancer research : an official journal of the American Association for Cancer Research
(Clin Cancer Res)
Vol. 8
Issue 11
Pg. 3401-6
(Nov 2002)
ISSN: 1078-0432 [Print] United States |
PMID | 12429627
(Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antigens, CD34
- Radioisotopes
- Granulocyte Colony-Stimulating Factor
- Rhenium
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Topics |
- Aged
- Antibodies, Monoclonal
- Antigens, CD34
(biosynthesis)
- Bone Marrow Cells
(radiation effects)
- Carcinoma, Squamous Cell
(pathology, therapy)
- Dose-Response Relationship, Radiation
- Female
- Granulocyte Colony-Stimulating Factor
(pharmacology)
- Head and Neck Neoplasms
(pathology, therapy)
- Humans
- Male
- Middle Aged
- Radioimmunotherapy
- Radioisotopes
(therapeutic use)
- Radiometry
- Recurrence
- Rhenium
(therapeutic use)
- Time Factors
- Tissue Distribution
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