Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
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.
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
Status | Completed |
Enrollment | 24 |
Est. completion date | |
Est. primary completion date | March 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Primary | Maximum tolerated dose of entinostat and isotretinoin in combination | 28 days | Yes | |
Secondary | Pharmacokinetics | Up to day 21 of course 2 | No | |
Secondary | 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 | Graded using the CTCAE version 3.0. Summarized by dose level. | Up to 30 days after completion of study treatment | Yes |
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