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

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

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. 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.

Key facts

Study ID

NCT00567931

Run by

National Cancer Institute (NCI)

People needed

52

Starts

2007-10-01

Expected to finish

2012-09-01

Last updated by the study team

2014-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed solid malignancy that is metastatic or unresectable and for which standard effective antineoplastic therapy does not exist or is no longer effective
• Patients are eligible for enrollment into the trial regardless of the types of previous therapies administered
• Patients with known brain metastases will only be eligible after their tumors have been treated with definitive resection and/or radiotherapy and they are neurologically stable for at least 1 month off steroids
• No known untreated brain metastases
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy > 4 months
• WBC ≥ 3,000/μL
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• No history of gastrointestinal disease causing malabsorption or obstruction, including, but not limited to, any of the following:
• Crohn's disease
• Celiac sprue
• Tropical sprue
• Bacterial overgrowth/blind-loop syndrome
• Strictures
• Adhesions
• Achalasia
• Bowel obstruction
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-method contraception during and for at least 1 month after completion of study treatment
• No history of allergic reactions (significant urticaria, angioedema, anaphylaxis) attributed to compounds of similar chemical or biologic composition to 1-methyl-d-tryptophan (including L-tryptophan or 5-hydroxy-tryptophan supplements)

Where it is running

• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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