NCT01191216

1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors

A Phase 1 Study of 1-Methyl-D-tryptophan (NSC-721782) in Combination With Docetaxel in Metastatic Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. The MTD of the 1-MT/docetaxel combination using CTCAE 4.0 criteria. SECONDARY OBJECTIVES: 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	1-methyl-d-tryptophan
DRUG	docetaxel
OTHER	diagnostic laboratory biomarker analysis
OTHER	pharmacological study

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-08-30
• Last updated: 2014-07-24

Locations

5 sites across 1 country: United States