Clinical trial · Interventional
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.
NCT00098891CI-TRIAL-00009112completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (44)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Grade III Lymphomatoid Granulomatosis | Adult Grade III Lymphomatoid Granulomatosis | ONTOLOGY_EXACT | 0.98 |
| Anaplastic Large Cell Lymphoma | Anaplastic Large Cell Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Intraocular Lymphoma | Primary Intraocular Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| entinostat | Drug | — | UNRESOLVED |
| isotretinoin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (entinostat, isotretinoin)
- description
- Patients 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.
- interventionNames
- Drug: entinostat
- Drug: isotretinoin
Primary outcomes (2)
- measure
- Dose limiting toxicities defined as an adverse event which is likely related to the study medication
- timeFrame
- 28 days
- description
- Graded using the CTCAE version 3.0.
- measure
- Maximum tolerated dose of entinostat and isotretinoin in combination
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * No symptomatic congestive heart failure * No unstable angina pectoris * No unstable cardiac arryhthmia * Able to take and retain oral medications * No malabsorption problems * No acute or chronic gastrointestinal condition * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception 1 month before, during, and 3 months after study treatment * No known HIV positivity * No weight loss \> 10% within the past 2 months * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to MS-275 or isotretinoin * No other uncontrolled illness * No ongoing or active infection * No seizure disorder * No psychiatric illness or social situation that would preclude study participation * More than 4 weeks since prior anticancer vaccine therapy * More than 4 weeks since prior anticancer immunotherapy * No concurrent anticancer vaccine therapy * No concurrent anticancer immunotherapy * More than 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas, mitomycin, or other agents known to cause prolonged marrow supression) * No concurrent anticancer chemotherapy * More than 4 weeks since prior anticancer hormonal therapy except gonadotropin-releasing hormone (GnRH) agonist therapy for non-castrated patients with prostate cancer * Concurrent GnRH agonist therapy for non-castrated patients with prostate cancer allowed * Concurrent luteinizing hormone-releasing hormone agonist therapy allowed provided there is evidence of tumor progression * Concurrent adrenal steroid replacement therapy allowed * No concurrent ketoconazole as second-line hormonal treatment for prostate cancer * No concurrent corticosteroids except for treatment of refractory nausea or vomiting * No other concurrent anticancer hormonal therapy * More than 4 weeks since prior anticancer radiotherapy * More than 2 weeks since prior palliative radiotherapy * No concurrent anticancer radiotherapy * More than 4 weeks since prior major surgery * Recovered from all prior therapy * No prior MS-275 * No prior oral isotretinoin * Isotretinoin for the treatment of acne allowed provided \> 3 years since prior administration * More than 4 weeks since other prior anticancer therapy * No concurrent tetracycline * No concurrent high-dose vitamin A * No concurrent valproic acid * No other concurrent investigational agents * No other concurrent anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.