MS-275 in Treating Patients With Advanced Solid Tumors or Lymphoma

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Entinostat; Histone Deacetylase Inhibitors

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