The primary objectives are to evaluate the safety and tolerability of hLL1-DOX, and to determine the maximum tolerated dose (MTD) regimen (in terms of a dose and its associated dosing schedule). The secondary objectives are to obtain information on efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for subsequent studies.
Patients receive hLL1-DOX at one of 4 dose levels administered on Days 1, 4, 8 and 11 of 21-day treatment cycles which are continued in the absence of progression or unacceptable toxicity up to a total of 8 cycles. After treatment, follow-up will be done at 4, 8 and 12 weeks post-treatment and will continue to be done every 3 months for up to 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
hLL1-DOX is administered intravenously at one of 4 dose levels on days 1, 4, 8 and 11 of 21-day treatment cycles, with up to 8 cycles administered.
Helen F. Graham Cancer Center
Newark, Delaware, United States
MD Anderson Cancer Center Orlando
Orlando, Florida, United States
IU Health Goshen Center for Cancer Care
Goshen, Indiana, United States
UMass Memorial Cancer Center of Excellence
Worcester, Massachusetts, United States
Evaluate the safety and tolerability of hLL1-DOX
NCI CTCAE version 4.0 is used to grade all adverse events
Time frame: These assessments will be done routinely during treatment & changes at 4, 8 & 12 weeks after treatment
All patients who were treated and meet the efficacy criteria for response assessment will be included in the analysis of efficacy
For the primary efficacy evaluations, the proportion of responders (defined as patients with a best response of PR or CR) will be tabulated for each dose level. In addition, the progression-free survival (PFS, as measured from start of treatment to disease progression, death or last follow-up) will be summarized using Kaplan-Meier survival analysis methods. Similarly, for responders at each dose level, the duration of response (DR, as measured from time of first response to relapse or last follow-up) will also be summarized using Kaplan- Meier survival analysis methods, if appropriate.
Time frame: During treatment and the changes at 4, 8 and 12 weeks after treatment and then every 3 months for up to 2 years
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John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
U.T. MD Anderson Cancer Center Houston
Houston, Texas, United States