AzTrials
AzTrials

Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT01191216

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

A Phase 1 study testing 1-methyl-d-tryptophan, docetaxel and diagnostic laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
1-methyl-d-tryptophan, docetaxel and diagnostic laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
5 sitesUnited States
Study dates
Sep 2010to Aug 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 34Show fewer
  • 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
  • No history of gastrointestinal disease causing malabsorption or obstruction such as, but not limited to, Crohn's disease, celiac sprue, tropical sprue, bacterial overgrowth/blind loop syndrome, gastric bypass surgery, strictures, adhesions, achalasia, bowel obstruction, or extensive small bowel resection
  • No patients with any active autoimmune disease (i.e., psoriasis, extensive atopic dermatitis, asthma, IBD, M.S., uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason
  • Mild-intermittent asthma requiring ONLY occasional beta-agonist inhaler use or mild localized eczema allowed
  • No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction or percutaneous coronary interventions within the last 6 months, cardiac arrhythmia, active autoimmune diseases, or major psychiatric illness/social situations that would limit compliance with study requirements as judged by the primary investigator at each site
  • Patients with well-controlled, chronic medical conditions under the supervision of the patient's primary physician (i.e., hypertension, hyperlipidemia, coronary heart disease, diabetes mellitus) are eligible
  • No HIV-positive patients or those with other acquired/inherited immunodeficiencies
  • No patients with more than one active malignancy at the time of enrollment
  • No history of allergic reactions (significant urticaria, angioedema, anaphylaxis) attributed to compounds of similar chemical or biologic composition to 1-methyl-d-tryptophan (this wouldi nclude L-tryptophan or 5-hydroxy-tryptophan supplements) or history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80
  • No patients with an allo-transplant of any kind (this would include those with a xenograft heart valve)
  • No prior treatment with experimental systemic immunotherapies such as CTLA-4 mAb (with the exception of vaccines)
  • No patients who have received any prior experimental active immunotherapy consisting of targeted monoclonal antibodies or pharmaceutical compounds
  • Patients who have received prior experimental vaccine may be enrolled if approved by the PI
  • Patients who have received commercially available active immunotherapies such as adjuvant interferon must have completed therapy over 1 year prior to enrollment and have no evidence of autoimmune sequelae
  • Prior therapy with approved monoclonal antibodies such as bevacizumab, cetuximab, panitumumab, or trastuzumab allowed
  • No patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients may not have received docetaxel in the metastatic setting previously, but are eligible for the trial if they received docetaxel in the adjuvant setting and at least one year elapsed between completion of adjuvant chemotherapy and disease recurrence
  • Patients may have received any number of prior chemotherapy treatments
  • Patients may not be concomitantly receiving any other investigational agents or standard therapies with the intent of treating their malignancy while on study
  • No supplements containing L-tryptophan or derivatives there of are allowed to be taken while on study

Who cannot join

None listed.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Billings Clinic

    Billings, Montana, 59107-7000

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 1 Study of 1-Methyl-D-tryptophan (NSC-721782) in Combination With Docetaxel in 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. The MTD of the 1-MT/docetaxel combination using CTCAE 4.0 criteria.

SECONDARY OBJECTIVES:

  1. 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.

Being tested
1-methyl-d-tryptophan, docetaxel, diagnostic laboratory biomarker analysis, pharmacological study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1-methyl-d-tryptophanDrug

    Also called indoximod

  • docetaxelDrug

    Also called RP 56976, Taxotere, TXT

  • diagnostic laboratory biomarker analysisOther

  • pharmacological studyOther

    Also called pharmacological studies

Study groups in NCT01191216
Study groupRoleWhat they receive
Arm IExperimentalPatients 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).
Receives: Drug: 1-methyl-d-tryptophan; Drug: docetaxel; Other: diagnostic laboratory biomarker analysis; Other: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 21 days

Secondary outcomes (2)

  1. PK data

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

  2. Overall objective response rate per RECIST criteria

    The analysis will be descriptive in nature as it will include patients with metastatic solid tumors.

    Measured: From the start of the treatment until disease progression/recurrence

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01191216
Sponsor's protocol ID
NCI-2011-02528
Other IDs
NCI-2011-02528, CDR0000684389, MCC-16264, MCC16264, 8784, N01CM00100, P30CA076292
Status last verified
Apr 2014
First submitted
27 Aug 2010
Last updated
24 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 1-methyl-d-tryptophan, docetaxel and diagnostic laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD defined as the dose level in which 1 of 6 patients experiences DLT assessed using CTCAE version 4.0 (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01191216.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in