1-Methyl-D-Tryptophan in Treating Patients With Metastatic or Refractory Solid Tumors That Cannot Be Removed By Surgery

00:28 EDT 30th March 2015 | BioPortfolio


RATIONALE: Biological therapies, such as 1-methyl-D-tryptophan, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stimulating the immune system.

PURPOSE: This phase I trial is studying the side effects and best dose of 1-methyl-D-tryptophan in treating patients with metastatic or refractory solid tumors that cannot be removed by surgery.




- To assess the toxicity, safety, and pharmacokinetics of escalating doses of 1-methyl-d-tryptophan (1-MT), a competitive inhibitor of the enzyme indoleamine 2,3-dioxygenase (IDO), in patients with advanced malignancies.

- To establish a maximally tolerated dose (MTD) or maximally biological effective dose (MBED) of 1-MT for future phase II and III trials.


- To assess the ratio of kynurenine to tryptophan in patient blood samples as a means of assessing the effect of 1MT on in vivo IDO activity.

- To ascertain the ability of 1-MT to decrease the number of T-regulatory cells thereby allowing the immune system to target tumor antigens more effectively.

- To analyze the IDO expression of different tumor types through IDO immunohistochemical staining of paraffin-preserved specimens.

- To perform high performance liquid chromatography on patient urine samples to assess how 1-MT is cleared renally.

OUTLINE: This is a multicenter study.

Patients receive oral 1-methyl-d-tryptophan (1-MT) once or twice daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Blood and urine samples are assessed to characterize the pharmacokinetics of 1-MT and renal clearance rate by high performance liquid chromatography, measure tryptophan and kynurenine levels by functional assays, and measure the response of regulatory CD4+ CD25+ T cells by intracellular staining and flow cytometry. Paraffin-embedded tissue samples are analyzed for indoleamine 2,3-dioxygenase (IDO) expression by immunohistochemical staining.

After completion of study treatment, patients are followed up for 4 weeks.

Study Design

Primary Purpose: Treatment


Unspecified Adult Solid Tumor, Protocol Specific


1-methyl-d-tryptophan, flow cytometry, high performance liquid chromatography, immunohistochemistry staining method, laboratory biomarker analysis, pharmacological study


H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
United States




National Cancer Institute (NCI)

Results (where available)

View Results


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