RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of FR901228 in treating patients who have refractory thyroid cancer or other advanced cancer.

OBJECTIVES:

• Determine the maximum tolerated dose of FR901228 (romidepsin) in patients with advanced cancer .
• Determine the biologically effective dose of this drug in these patients.
• Determine the effects of this drug on gene expression in these patients.
• Determine whether this drug increases radioiodide uptake in patients with radioiodine-refractory non-medullary thyroid cancer.
• Determine the effect of this drug on the expression of sodium-iodide symporter transporter in these thyroid cancer patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 3, and 5. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Once the MTD is determined, an additional cohort of 10 patients with radioiodine-refractory non-medullary thyroid cancer are treated at that dose.

PROJECTED ACCRUAL: Approximately 3-56 patients (10 with radioiodine-refractory non-medullary thyroid cancer) will be accrued for this study within 17-21 months.

• Head and Neck Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed cancer for which there is no known standard therapy capable of extending life expectancy (closed to accrual as of ½8/08)

  • No acute leukemia
• Evaluable disease
• No prior or concurrent CNS metastases

• Thyroid cancer cohort (enrolled after the maximum tolerated dose for study drug has been determined):

  • Radioiodine (RAI)-refractory non-medullary thyroid cancer
  • Progressive disease after total or near-total thyroidectomy and RAI therapy
  • Evidence of no or minimal RAI uptake on RAI whole body scan
  • 24-hour urinary iodine no greater than 70 µg/day

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count ≥1,000/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST ≤ 3 times ULN

Renal

• Creatinine ≤ 1.5 times ULN OR
• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• Ejection fraction > 50% by echocardiogram or cardiac MRI (45% by MUGA)
• No myocardial infarction within the past 12 months
• No active coronary disease (e.g., angina) as defined by Canadian class II-IV
• No QTc > 480 msec
• No congenital long QT syndrome
• No evidence of cardiac ischemia (e.g., ST depression ≥ 2 mm) as assessed by ECG
• No NYHA class II-IV congestive heart failure
• No history of sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes, or cardiac arrest unless patient has an automatic implantable cardioverter defibrillator
• No dilated, hypertrophic, or restrictive cardiomyopathy from prior treatment or other causes
• No uncontrolled hypertension (i.e., systolic blood pressure [BP] ≥ 160 mm Hg or diastolic BP ≥ 95 mm Hg)
• No cardiac arrhythmia requiring anti-arrhythmic medication other than beta blocker or calcium channel blocker
• No Mobitz II second degree heart block unless patient has pacemaker

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after study participation
• HIV negative
• No other serious uncontrolled medical illness
• No uncontrolled infection
• No other concurrent malignancies that have not been curatively treated
• 24-hour urinary iodine values ≤ 150 μg/day

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin and 8 weeks for UCN-01)
• No other concurrent chemotherapy, including topical treatments

Endocrine therapy

• Concurrent corticosteroids for non-responding lesions allowed provided dose is stable

  • Corticosteroid therapy for cancer treatment may not be initiated after start of study

Radiotherapy

• See Disease Characteristics
• More than 3 months since prior RAI therapy*
• More than 3 months since prior IV iodinated contrast or other large iodine loads (i.e., CT scan, amiodarone, or saturated solution of potassium iodide)*
• Concurrent palliative localized external beam radiotherapy for metastatic cancer allowed provided treatment field does not include significant cardiac muscle and patient is responding to FR901228 (depsipeptide) NOTE: *Thyroid cancer cohort only

Surgery

• See Disease Characteristics
• Concurrent palliative surgery for metastatic cancer allowed provided patient is responding to FR901228

Other

• At least 1 week since prior complementary and alternative medications (e.g., unprescribed dietary supplements or herbal remedies)
• No concurrent complementary and alternative medications
• No concurrent agents that are known to cause QTc prolongation
• No concurrent digitalis