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

NCT01191216 | Completed Phase 1

• 7 other identifiers: NCI-2011-02528CDR0000684389MCC-16264MCC162648784N01CM00100P30CA076292
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• MTD defined as the dose level in which 1 of 6 patients experiences DLT assessed using CTCAE version 4.0

  21 days

Secondary Outcomes (2)

• PK data

  0, 1, 2, 4, 8, 12, 24, and 48 hours

• Overall objective response rate per RECIST criteria

  From the start of the treatment until disease progression/recurrence

Study Arms (1)

Arm I

EXPERIMENTAL

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).

Drug: 1-methyl-d-tryptophan; Drug: docetaxel; Other: diagnostic laboratory biomarker analysis; Other: pharmacological study

Interventions

1-methyl-d-tryptophan DRUG

Also known as: indoximod

Arm I

docetaxel DRUG

Also known as: RP 56976, Taxotere, TXT

Arm I

diagnostic laboratory biomarker analysis OTHER

Arm I

pharmacological study OTHER

Also known as: pharmacological studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed metastatic solid malignancy
• Preference will be given to patients whose malignancies are treated with docetaxel as part of routine therapy
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
• 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
• ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
• Life expectancy of greater than 4 months
• Leukocytes ≥ 3,000/μL
• Absolute neutrophil count ≥ 1,500/μL
• Platelets ≥ 100,000/μL
• Total bilirubin normal
• AST/ALT ≤ 1.5 times upper limit of normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Negative pregnancy test
• Not pregnant or nursing
• Sexually active women of child-bearing potential must agree to use two forms of contraception (hormonal and barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for a minimum of 1 month after completion of the study; men should be discouraged from fathering children while on treatment

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (5)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Billings Clinic

Billings, Montana, 59107-7000, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

1-methyltryptophan; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Hatem Soliman

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2010
• First Posted: August 30, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 24, 2014

Record last verified: 2014-04

Locations

US (5)