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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00617422 |
The purpose of this study is to:
Another strategy being investigated involves using the body's own disease fighting immune system to attack cancer cells and kill them. It is hoped that this will allow the body to rid itself of cancer more effectively with less severe treatment related side effects. Many cancers have developed ways to avoid being targeted by your immune system. The drug 1-methyl-D-tryptophan (shortened to 1-MT) is being studied for the first time in humans as a way to stop the ability of these cancers to avoid being targeted by your immune system. Experiments with cancer cells and animals with tumors suggest that this drug is well tolerated and is able to boost the ability of the immune system to kill cancer cells. This study will figure out how safe the drug is in humans and what dose should be given in later trials that see how effective the drug is in achieving its goal.
Condition | Intervention | Phase |
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Advanced Malignancies |
Drug: 1-Methyl-D-tryptophan |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1 Study of 1-Methyl-D-tryptophan in Patients With Advanced Malignancies |
Estimated Enrollment: | 24 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Phase I Dose Escalation
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Drug: 1-Methyl-D-tryptophan
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Treatment will be administered on an outpatient basis. The medication will be orally administered once daily an hour prior to breakfast with water. Each treatment cycle is comprised of 28 days. The treatment is continuous with no breaks in between cycles. 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 will be treated for 4 cycles. Those with partial or complete responses will continue on the study medication (also dependent on study drug availability) for up to 2 more cycles. No investigational or commercial agents or therapies other than those described 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.
There will be two planned interim analysis points with a temporary pause in new patient accrual until the analysis is complete. An analysis of the available PK data and toxicities will be performed upon completion of the 800 mg dose level. This will provide investigators an opportunity to use early PK data to anticipate future study drug needs, alter the dose of 1-MT capsules as necessary, change the dosing schedule, or the dose escalation of 1-MT based on observed serum drug levels for later cohorts. A second analysis after completion of the 1600 mg dose level will analyze oral tolerance of the drug using once daily dosing prior to escalation to higher dose levels. If there is significant oral intolerance due to the quantity of pills ingested, the protocol may be amended to allow twice daily dosing for later dose level cohorts. Also at both analysis points the PK data will be analyzed to see if saturation has been achieved. If saturation has clearly been reached, accrual to the next higher dose level will be suspended until the sponsor and the FDA can assess the need to expand the current dose cohort or modify the dose escalation scheme.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
History of allergic reactions attributed to compounds of similar chemical or biologic composition to
1-Methyl-D-tryptophan.
Contact: Scott Antonia, M.D., PhD. | 813-745-3883 | scott.antonia@moffitt.org |
Contact: Leticia Tetteh, R.N. | 813-745-4617 | leticia.tetteh@moffitt.org |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Scott Antonia, M.D., PhD. 813-745-3883 scott.antonia@moffitt.org | |
Contact: Anne Dellaportas, R.N. 813-745-4616 anne.dellaportas@moffitt.org | |
Principal Investigator: Scott Antonia, M.D., PhD. | |
Sub-Investigator: Alberto Chiappori, M.D. | |
Sub-Investigator: Richard Lush, PhD. | |
Sub-Investigator: Susan Minton, D.O. | |
Sub-Investigator: Hatem Soliman, M.D. | |
Sub-Investigator: Daniel Sullivan, M.D. | |
Sub-Investigator: Gregory Springett, M.D., Ph.D. | |
United States, Virginia | |
VCU Massey Cancer Center | Recruiting |
Richmond, Virginia, United States, 23298 | |
Contact: Christine Birdsell, R.N. 804-828-0422 cbirdsell@vcu.edu | |
Sub-Investigator: John Roberts, M.D. |
Principal Investigator: | Scott Antonia, M.D., PhD. | H. Lee Moffitt Cancer Center and Research Institute |
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute ( Scott Antonia, M.D., PhD. ) |
Study ID Numbers: | MCC-15267, USFIRB#103007c, NCI-8045 |
Study First Received: | February 5, 2008 |
Last Updated: | August 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00617422 History of Changes |
Health Authority: | United States: Institutional Review Board |
IDO expression active solid tumor immune system Immunomodulatory |
Tryptophan Psychotropic Drugs Antidepressive Agents, Second-Generation Antidepressive Agents |
Tryptophan Neoplasms Therapeutic Uses Psychotropic Drugs |
Antidepressive Agents, Second-Generation Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |