Erratum to “NCCAM/NCI Phase 1 Study of Mistletoe Extract and Gemcitabine in Patients with Advanced Solid Tumors”

Table 4

Dose limiting toxicities by dose level.

Stage I (fixed GEM dose of 750 mg/m^2)			Stage II (fixed mistletoe dose, established in stage 1)
Level	𝑁	DLT	Level/dosage	𝑁	DLT	Action taken per protocol
(1); (escalating daily mistletoe injections, reaching: 20 mg/day)	3	None	(6); (250 mg/day mistletoe; 900 mg/m^2 GEM on day 1/8 of 3-week cycle)	7	Grade 4 neutropenia	Dose reduced; enrolled 3 more patients at this dose level.
(2); (escalating daily mistletoe injections, reaching: 50 mg/day)	3	None	(7); (250 mg/day mistletoe; 1080 mg/m^2 GEM on day 1/8 of 3-week cycle)	7	Grade 4 thrombocytopenia	Dose reduced; enrolled 3 more patients at this dose level.
(3); (escalating daily mistletoe injections, reaching: 100 mg/day)	3	None	(8)*; (250 mg/day mistletoe; 1300 mg/m^2 GEM on day 1/8 of 3-week cycle)	6	None	N/A
(4); (escalating daily mistletoe injections, reaching: 200 mg/day)	6	None	(9); (250 mg/day mistletoe; 1560 mg/m^2 GEM on day 1/8 of 3-week cycle)	4	Grade 3 cellulitis^a; grade 4 acute renal failure^b; grade 4: thrombocytopenia^c	^amistletoe therapy withheld; patient rechallenged and developed hypersensitivity reaction. Mistletoe discontinued; ^bPt. treated for renal failure and subsequently withdrawn from study; ^cPt. hospitalized d/t other AE; Maximum tolerated dose reached per protocol.
(5); (escalating daily mistletoe injections, reaching: 250 mg/day)	5	None

∗Per study protocol, this level represents the maximum tolerated dose, as 3 DLT’s were observed in the subsequent dose level.