MS-275 in Treating Patients With Advanced Solid Tumors or... | NCT00020579 | Trialant
NCT00020579
Sponsor
National Institutes of Health Clinical Center (CC)
Status
Completed
Last Update Posted
Mar 15, 2012Estimated
Enrollment
75Estimated
Phase
Phase 1
Conditions
Cancer
Interventions
entinostat
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00020579
Obsolete or Duplicate NCT IDs
NCT00012571
Organization Study
010124
Secondary IDs
ID
Type
Description
Link
01-C-0124
NCI-2792
CDR0000068615
Brief Title
MS-275 in Treating Patients With Advanced Solid Tumors or Lymphoma
Official Title
A Phase I Study of an Oral Histone Deacetylase Inhibitor, MS-275, in Refractory Solid Tumors and Lymphomas
Acronym
Not provided
Organization
National Institutes of Health Clinical Center (CC)NIH
Status Module
Record Verification Date
Mar 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Mar 2001
Primary Completion Date
Apr 2008Actual
Completion Date
Oct 2008Actual
First Submitted Date
Jul 11, 2001
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 14, 2012
Last Update Posted Date
Mar 15, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
National Institutes of Health Clinical Center (CC)NIH
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase I trial is studying the side effects and best dose of MS-275 in treating patients with advanced solid tumors or lymphoma.
Detailed Description
OBJECTIVES:
Determine the dose-limiting toxicity and maximum tolerated dose of MS-275 in patients with advanced solid tumors or lymphomas.
Determine the profile of adverse events, including changes in laboratory parameters, in patients treated with this drug.
Assess the pharmacology and pharmacokinetics of this drug in these patients.
Design MS-275 regimens with possibly more frequent dose administration based on the pharmacology of MS-275 using the schedule in this study.
Determine the antineoplastic activity of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive oral MS-275 once on day 1. Courses repeat every 2 weeks (every 2-week schedule). Alternatively, patients receive oral MS-275 once on days 1, 8, 15, and 22 (weekly schedule). Courses repeat every 6 weeks. Treatment for both schedules continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of MS-275 on the every 2-week schedule until the maximum tolerated dose (MTD) is determined. Once the MTD for the every 2-week schedule is determined, patients receive treatment on the weekly schedule as above. The MTD is then determined for the weekly schedule. The MTD for both schedules is defined as the dose preceding that at which at least 2 of up to 6 patients experience dose-limiting toxicity. Once the MTD is determined for the weekly schedule, up to 3 additional patients are accrued to receive MS-275 at the MTD of the weekly schedule.
Disease status is assessed every 3 months.
PROJECTED ACCRUAL: A total of 50-75 patients will be accrued for this study.
Conditions Module
Conditions
Cancer
Keywords
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
small intestine lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV adult Burkitt lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
75Estimated
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
entinostat
Drug
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose-limiting toxicities and maximum tolerated dose
Pharmacology and pharmacokinetics
Secondary Outcomes
Measure
Description
Time Frame
Acetylation of histones in peripheral blood
Tumor response by CT scan every 12 weeks
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy that is metastatic or unresectable and for which no effective standard curative or palliative therapy exists
Brain metastases allowed provided both of the following criteria are met:
Received treatment for the brain metastases
Stable for ≥ 6 months without steroids or antiseizure medications
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-2 OR
Karnofsky 50-100%
Life expectancy:
More than 3 months
Hematopoietic:
WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN) (≤ 3 mg/dL for patients with Gilbert's syndrome)
AST/ALT no greater than 2.5 times ULN
Albumin at least 75% of lower limit of normal
Renal:
Creatinine normal OR
Creatinine clearance at least 60 mL/min
Cardiovascular:
Cardiac ejection fraction normal by MUGA
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Adequate oral intake
No weight loss of more than 10% of actual body weight within the past 2 months
No history of allergic reaction to compounds of similar chemical or biological composition to study drug
No other uncontrolled illness
No ongoing or active infection
No seizure disorder
No psychiatric illness or social situation that would preclude study compliance
No acute or chronic gastrointestinal conditions (e.g., peptic ulcer or colitis) within the past 2 months that would interfere with drug tolerance or absorption
Willing and able to self-administer and document doses of MS-275
PRIOR CONCURRENT THERAPY:
Biologic therapy:
At least 4 weeks since prior anticancer vaccine therapy and recovered
No concurrent immunotherapy
Chemotherapy:
At least 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
At least 8 weeks since prior UCN-01 and recovered
No concurrent chemotherapy
Endocrine therapy:
At least 4 weeks since prior anticancer hormonal therapy (except gonadotropin-releasing hormone [GnRH] agonists) and recovered
Concurrent corticosteroids for physiological replacement, as antiemetic therapy, or for an ongoing condition allowed
Must be on a stable dose during the past 4 weeks
No concurrent anticancer hormonal therapy except GnRH agonists for noncastrated patients with prostate cancer
Radiotherapy:
At least 4 weeks since prior anticancer radiotherapy and recovered
No concurrent radiotherapy
Concurrent localized radiotherapy to a single lesion allowed if the patient achieves at least a partial response
Surgery:
At least 3 weeks since prior major surgery
Other:
No other concurrent investigational or commercial antineoplastic therapies
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Shivaani Kummar, MD
NCI - Medical Oncology Branch
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
National Naval Medical Center
Bethesda
Maryland
20889-5000
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
Ryan QC, Headlee D, Sparreboom A, et al.: A phase I trial of an oral histone deacetylase inhibitor, MS-275, in advanced solid tumor and lymphoma patients. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-802, 2003.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009369
Neoplasms
D016410
Lymphoma, T-Cell, Cutaneous
D008224
Lymphoma, Follicular
D008228
Lymphoma, Non-Hodgkin
D016403
Lymphoma, Large B-Cell, Diffuse
D016400
Lymphoma, Large-Cell, Immunoblastic
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D002051
Burkitt Lymphoma
D054218
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
D064090
Intraocular Lymphoma
D020522
Lymphoma, Mantle-Cell
D007119
Immunoblastic Lymphadenopathy
D017728
Lymphoma, Large-Cell, Anaplastic
D009182
Mycosis Fungoides
D012751
Sezary Syndrome
D018442
Lymphoma, B-Cell, Marginal Zone
D015451
Leukemia, Lymphocytic, Chronic, B-Cell
Ancestor Terms
ID
Term
D016399
Lymphoma, T-Cell
D008223
Lymphoma
D009370
Neoplasms by Histologic Type
D008232
Lymphoproliferative Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C118739
entinostat
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
stage IV adult T-cell leukemia/lymphoma
recurrent adult T-cell leukemia/lymphoma
primary central nervous system non-Hodgkin lymphoma
intraocular lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma
stage IV mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma
male breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent pancreatic cancer
stage III pancreatic cancer
recurrent colon cancer
stage III colon cancer
stage IV colon cancer
recurrent rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent ovarian epithelial cancer
recurrent ovarian germ cell tumor
stage III ovarian epithelial cancer
stage III ovarian germ cell tumor
stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor
recurrent malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
recurrent cervical cancer
stage III cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer
recurrent endometrial carcinoma
stage III endometrial carcinoma
stage IV endometrial carcinoma
fallopian tube cancer
primary peritoneal cavity cancer
recurrent uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
recurrent vaginal cancer
stage III vaginal cancer
stage IVA vaginal cancer
stage IVB vaginal cancer
recurrent vulvar cancer
stage III vulvar cancer
stage IV vulvar cancer
recurrent anal cancer
stage IIIA anal cancer
stage IIIB anal cancer
stage IV anal cancer
recurrent esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent gastric cancer
stage III gastric cancer
stage IV gastric cancer
recurrent extrahepatic bile duct cancer
unresectable extrahepatic bile duct cancer
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent basal cell carcinoma of the lip
recurrent squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip
stage III squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage III lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage III midline lethal granuloma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
metastatic parathyroid cancer
recurrent parathyroid cancer
recurrent salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
recurrent bladder cancer
recurrent gallbladder cancer
stage III bladder cancer
stage IV bladder cancer
unresectable gallbladder cancer
recurrent renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer
stage III Wilms tumor
stage IV Wilms tumor
stage V Wilms tumor
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter