- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University/Winship Cancer Institute
-
-
Montana
-
Billings, Montana, United States, 59107-7000
- Billings Clinic
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
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).
|
Other Names:
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MTD defined as the dose level in which 1 of 6 patients experiences DLT assessed using CTCAE version 4.0
Time Frame: 21 days
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK data
Time Frame: 0, 1, 2, 4, 8, 12, 24, and 48 hours
|
0, 1, 2, 4, 8, 12, 24, and 48 hours
|
|
Overall objective response rate per RECIST criteria
Time Frame: From the start of the treatment until disease progression/recurrence
|
The analysis will be descriptive in nature as it will include patients with metastatic solid tumors.
|
From the start of the treatment until disease progression/recurrence
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hatem Soliman, H. Lee Moffitt Cancer Center and Research Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2011-02528 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA076292 (U.S. NIH Grant/Contract)
- N01CM00100 (U.S. NIH Grant/Contract)
- CDR0000684389
- MCC-16264
- MCC16264 (Other Identifier: H. Lee Moffitt Cancer Center and Research Institute)
- 8784 (CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Unspecified Adult Solid Tumor, Protocol Specific
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingCollection and Storage of Tissue Samples From Patients Undergoing Surgery For Suspected Solid TumorsUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Kantonsspital GraubuendenUnknownUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificSwitzerland
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Vanderbilt UniversityNational Cancer Institute (NCI)TerminatedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
University of ChicagoNational Cancer Institute (NCI)CompletedSirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed By SurgeryUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)WithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyWithdrawnUnspecified Childhood Solid Tumor, Protocol Specific | Unspecified Adult Solid Tumor, Protocol Specific | Hematopoietic/Lymphoid CancerUnited States
-
University of Texas Southwestern Medical CenterRecruitingUnspecified Adult Solid Tumor, Protocol SpecificUnited States
Clinical Trials on pharmacological study
-
National Cancer Institute (NCI)TerminatedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
National Cancer Institute (NCI)CompletedExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Nodal Marginal Zone B-cell Lymphoma | Recurrent Adult Burkitt Lymphoma | Recurrent Adult Diffuse Large Cell Lymphoma | Recurrent Adult Diffuse Mixed Cell Lymphoma | Recurrent Adult Diffuse Small Cleaved Cell Lymphoma and other conditionsUnited States
-
Universitätsmedizin MannheimHeidelberg UniversityUnknownLung Cancer | Brain and Central Nervous System TumorsGermany
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI); Peloton Therapeutics, Inc.CompletedRecurrent GlioblastomaUnited States
-
National Cancer Institute (NCI)TerminatedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
National Cancer Institute (NCI)CompletedUnspecified Childhood Solid Tumor, Protocol Specific | Recurrent Childhood Soft Tissue Sarcoma | Recurrent Childhood Brain Stem Glioma | Recurrent Childhood Visual Pathway Glioma | Childhood Central Nervous System Germ Cell Tumor | Childhood Central Nervous System Choriocarcinoma | Childhood Central... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Recurrent Mycosis Fungoides/Sezary SyndromeUnited States
-
National Cancer Institute (NCI)CompletedUnspecified Adult Solid Tumor, Protocol Specific | Male Breast Cancer | Stage IV Breast Cancer | Stage IV Ovarian Epithelial Cancer | Stage IV Renal Cell Cancer | Recurrent Renal Cell Cancer | Recurrent Breast Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage...United States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedMyeloid Proliferations Associated With Down SyndromeUnited States, Canada, Australia, Puerto Rico