A Phase 1 Study of 1-Methyl-D-tryptophan in Patients With Advanced Malignancies
Treatment will be administered on an outpatient basis. The medication will be orally
administered twice daily an hour prior to breakfast and dinner with water. Each treatment
cycle is comprised of 28 days. The treatment is continuous with no breaks in between
cycles. For dose levels 6 & 7, no single dose pharmacokinetic (PK) analysis will be done
(as this has already been done) and patients will be monitored in the Clinical Research Unit
(CRU) for one hour following first dose. Starting with dose level 8, single dose PK will be
performed as follows. Patients will be monitored during administration of their first dose
by clinical research nursing staff while pharmacokinetics tests are performed over the
initial 12 hours. This includes documenting vital signs and clinical status in hourly
intervals for the first 4 hours after administration then every 4 hours thereafter if the
patient is stable. Any acute change in patient status will be evaluated and treated by the
research medical staff. In order to collect reliable single dose pharmacokinetic data,
patients will take their first dose of 1-MT and not take another dose until day 3 of the
first cycle. All doses will be recorded by the patient using the pill diary form and
confirmed using pill counts by the research staff at each biweekly visit. The pill diary
forms will be turned into the research staff at the end of each treatment cycle. Patients
who demonstrate radiologically confirmed progressive disease will be removed from the study.
Those with stable disease or better will be treated for up to 12 cycles. No
investigational or commercial agents or therapies other than those described below may be
administered with the intent to treat the patient's malignancy. The evaluations and tests
will be performed on the schedule outlined in the schema and study calendar sections. An
autoimmunity symptom checklist will be completed at each visit by the evaluating medical
staff.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
The study is a phase I trial with the primary objective of establishing the MTD or maximally biological effective dose (MBED) for a future phase II trial. A 3+3 dose escalation scheme will be used.
Up to 12 months
No
Scott Antonia, M.D., PhD.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
MCC-15267
NCT00617422
October 2007
November 2012
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
VCU Massey Cancer Center | Richmond, Virginia 23298 |