MS-275 and Isotretinoin in Treating Patients With Metastatic or Advanced Solid Tumors or Lymphomas
A Phase I Study of an Oral Histone Deacetylase Inhibitor, MS-275 (NSC 706995, IND 61,198), in Combination With 13-Cis-Retinoic Acid in Metastatic Progressive Cancer.
4 other identifiers
interventional
24
1 country
1
Brief Summary
Phase I trial to study the effectiveness of combining MS-275 with isotretinoin in treating patients who have metastatic or advanced solid tumors or lymphomas. MS-275 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Isotretinoin may help cancer cells develop into normal cells. MS-275 may increase the effectiveness of isotretinoin by making cancer cells more sensitive to the drug. MS-275 and isotretinoin may also stop the growth of solid tumors or lymphomas by stopping blood flow to the cancer. Combining MS-275 with isotretinoin may kill more cancer cells
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 8, 2004
CompletedFirst Posted
Study publicly available on registry
December 9, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedJanuary 24, 2013
January 1, 2013
3.4 years
December 8, 2004
January 23, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Dose limiting toxicities defined as an adverse event which is likely related to the study medication
Graded using the CTCAE version 3.0.
28 days
Maximum tolerated dose of entinostat and isotretinoin in combination
28 days
Secondary Outcomes (2)
Pharmacokinetics
Up to day 21 of course 2
Adverse events defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment
Up to 30 days after completion of study treatment
Study Arms (1)
Treatment (entinostat, isotretinoin)
EXPERIMENTALPatients receive oral MS-275 once on days 1, 8, and 15 and oral isotretinoin twice daily on days 1-21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Interventions
Given orally
Given orally
Eligibility Criteria
You may qualify if:
- Histologically confirmed solid tumor or lymphoma
- Metastatic, progressive, refractory, or unresectable disease
- Not amenable to standard curative measures
- No known brain metastases
- Performance status - ECOG 0-2
- More than 3 months
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- WBC ≥ 3,000/mm\^3
- Hemoglobin \> 9 g/dL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN
- No suspected Gilbert's syndrome
- Creatinine ≤ 1.5 times ULN
- Creatinine clearance ≥ 60 mL/min
- +43 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins University
Baltimore, Maryland, 21287-8936, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roberto Pili
Johns Hopkins University
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
December 8, 2004
First Posted
December 9, 2004
Study Start
October 1, 2004
Primary Completion
March 1, 2008
Last Updated
January 24, 2013
Record last verified: 2013-01