1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
This phase I trial is studying the side effects and best dose of giving 1-methyl-d-tryptophan and docetaxel together in treating patients with metastatic solid tumors. Biological therapies, such as 1-methyl-d-tryptophan, may stop the growth of tumor cells by stimulating the immune system and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving 1-methyl-d-tryptophan with chemotherapy may kill more tumor cells.
Unspecified Adult Solid Tumor, Protocol Specific
Other: diagnostic laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of 1-Methyl-D-tryptophan (NSC-721782) in Combination With Docetaxel in Metastatic Solid Tumors|
- MTD defined as the dose level in which 1 of 6 patients experiences DLT assessed using CTCAE version 4.0 [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
- PK data [ Time Frame: 0, 1, 2, 4, 8, 12, 24, and 48 hours ] [ Designated as safety issue: No ]
- Overall objective response rate per RECIST criteria [ Time Frame: From the start of the treatment until disease progression/recurrence ] [ Designated as safety issue: No ]The analysis will be descriptive in nature as it will include patients with metastatic solid tumors.
|Study Start Date:||September 2010|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive oral 1-methyl-d-tryptophan twice daily on days 1-21 and docetaxel IV over 1 hour on day 1 (in course one patients receive 1-methyl-d-tryptophan once daily on days 1 and 3-21).
Other Name: indoximodDrug: docetaxel
Other Names:Other: diagnostic laboratory biomarker analysis Other: pharmacological study
Other Name: pharmacological studies
I. The MTD of the 1-MT/docetaxel combination using CTCAE 4.0 criteria.
I. Determination of PK data for the combination of docetaxel plus oral 1-MT.Overall objective response rate (CR, PR) per RECIST criteria.
OUTLINE: This is a dose-escalation study.
Patients receive oral 1-methyl-d-tryptophan twice daily on days 1-21 and docetaxel IV over 1 hour on day 1 (in course one patients receive 1-methyl-d-tryptophan once daily on days 1 and 3-21). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for pharmacokinetic and correlative studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191216
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Emory University/Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Montana|
|Billings, Montana, United States, 59107-7000|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Hatem Soliman||H. Lee Moffitt Cancer Center and Research Institute|