Clinical trial · Interventional
MS-275 in Treating Patients With Advanced Solid Tumors or Lymphoma
A Phase I Study of an Oral Histone Deacetylase Inhibitor, MS-275, in Refractory Solid Tumors and Lymphomas
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| entinostat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Dose-limiting toxicities and maximum tolerated dose
- measure
- Pharmacology and pharmacokinetics
Secondary outcomes (2)
- measure
- Acetylation of histones in peripheral blood
- measure
- Tumor response by CT scan every 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTRyan 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.