Patients must have serum chemistries (including potassium and magnesium) within 21 days prior to registration to obtain baseline values
Abnormal serum calcium, magnesium, or potassium levels
Documented within 14 days of registration: Magnesium: >= 0.7 mmol/L
The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed).
The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin
Magnesium within normal range (supplementation is allowed)
Potassium and magnesium within normal range, patients may receive supplements to meet this requirement
Potassium and magnesium within normal range
Magnesium WNL
Magnesium within 0.85 to 1.25 x institutional normal limits
Patients whose electrolytes (sodium, potassium, calcium, magnesium) are abnormal or cannot be normalized with standard intervention on the day of treatment with study drug
Serum calcium, magnesium, and phosphorous with institutional normal limits (supplementation is permissible)
Magnesium WNL
Magnesium within normal limits prior to the first dose of study medication
Serum magnesium >= ILLN
Clinically significant abnormal serum potassium (regardless of potassium agent supplementation); serum calcium (ionic or binding to albumin post-adjusted) or serum magnesium (regardless of magnesium agent supplementation);
Magnesium > 1.2 and < 2.5 mEq
For Phase I and II: Serum potassium, magnesium, and calcium (normalized for albumin) levels should be at least within institutional normal limits.
Patients with electrolyte abnormalities at study entry defined as follows: Serum potassium < 3.5 mEq/L despite supplementation, or > 5.5 mEq/L; Serum magnesium above or below the institutional normal limit despite adequate management; Serum calcium (corrected for albumin levels) above or below institutional normal limit despite adequate management.
Clinically significant electrolyte disorders including sodium < 130 or > 145 and/or potassium < 3.0 or > 5.5 and/or magnesium < 1.8 or > 2.9
Normal magnesium (can be on oral supplementation)
Serum potassium, magnesium, and calcium levels normal per current Yale-New Haven Hospital (YNHH) lab medicine standards (may be corrected to those levels by supplementation during screening period) within 2 weeks prior to start of any therapy
Potassium, magnesium and phosphorus within the normal range for the institution (supplementation is permissible)
Serum potassium, magnesium and calcium levels which fall within normal limits or levels outside the normal range determined not to be clinically significant by the principal investigator (PI)
Within 14 days prior to registration: Magnesium within institution’s normal range
Serum potassium, magnesium, and calcium levels within 28 days before randomization must be within normal limits (WNL) for the lab within 28 days before randomization
The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chlorine (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator’s discretion
The following assessments are required within 14 days prior to registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; Note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator’s discretion
Serum calcium or magnesium outside the institutional range of normal
Within 14 days of subject registration: Potassium, calcium (corrected for serum albumin) and magnesium within IULN
Uncorrected severe electrolyte disorder, including severe potassium (< 3.0 mEq/L) or magnesium (< 1.0 mEq/L) deficiency
Serum magnesium within normal limits
Potassium (K) and magnesium (Mg) >= grade 2 toxicity
Serum magnesium within normal range (patients may receive magnesium supplementation to achieve normal levels)
Performed within 14 days of patient registration: Serum magnesium > 1.8 mg/dL(can be achieved with replacement)\r\n* NOTE: The package insert for the study drug, romidepsin, does not require subject blood levels of potassium (K) and magnesium (Mg) to be at a certain level; therefore in this study, we will require K > 3.8 and Mg > 1.8 for eligibility, but for the rest of the treatment parameters during the course of the study we will require these electrolytes to be within normal range (WNL)
The following assessments are required within 2 weeks prior to the start of registration: sodium (Na), potassium (K), chloride (Cl), glucose, calcium (Ca), magnesium (Mg), and albumin; note: patients with an initial magnesium < 0.5 mmol/L (1.2 mg/dl) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation (e.g., magnesium oxide) at the investigator’s discretion
Serum magnesium levels outside the laboratory’s reference range
Patient must have magnesium, calcium, glucose, potassium and sodium levels within normal limits
Serum potassium and magnesium-within normal limits (WNL)
Serum potassium, magnesium and calcium within normal limits (supplementation to maintain normal electrolyte levels is acceptable)
Obtained =< 7 days prior to registration: Magnesium within normal limits (WNL)
Patients with abnormal calcium, potassium, or magnesium levels that is or cannot be adequately corrected to =< grade 1 prior to initiation of study drugs
Calcium (Ca), magnesium (Mg), potassium (K) within normal
Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
Serum magnesium greater than or equal to 1.8 mg/dL
Magnesium (Mg) levels: preferred normal limits with no clinical abnormalities
Magnesium levels within normal limits
Serum potassium and magnesium levels within institutional normal limits; patients with low potassium and magnesium levels may be repleted to allow for protocol entry
Serum electrolyte values (sodium, potassium, magnesium, calcium) must be checked prior to enrollment and clinically significant abnormalities corrected prior to surgery/AdV-tk injection
Serum electrolyte values < Grade 2 (sodium, potassium, calcium, phosphorous and magnesium), per CTCAE v.4.03.
Subjects with > Grade 1 (high or low) serum potassium, magnesium, or calcium levels.
Serum potassium and magnesium levels within normal limits
Serum magnesium =< 1.4 mEq/L
Serum potassium, and magnesium within normal limits
Subjects with initial magnesium < 0.5 mmol/liter (1.2 mg/deciliter) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation
Serum magnesium > 1.3; electrolyte repletion is allowed to reach these values
Serum magnesium, calcium, and phosphorus must be within normal reference ranges as per local tests. [If initial screening results are outside of normal reference range, the Investigator may initiate appropriate measures to correct. However administration of FS102 may not proceed until the specified electrolytes have normalized.]
Serum calcium and magnesium within the normal range (or corrected with supplements)
Subject has any abnormalities in serum sodium, potassium, chloride, calcium and magnesium levels ? Grade 2 at screening (CTCAE Version 4.03).
Normal serum potassium magnesium levels
Serum potassium, magnesium, and calcium levels (corrected for albumin) outside the laboratory’s reference range despite correction
Must have adequate bone marrow and renal/hepatic function at the screening visit (?7 days preceding the lab assessment): i. ANC ? 1,500/mm3, without G-CSF ii. Platelets ? 100,000/mm3, without transfusion iii. Hemoglobin ? 9 g/dL, without transfusion support iv. AST or ALT ? 3 × ULN v. Total serum bilirubin ? 1.5 times ULN vi. Serum creatinine ? ULN vii. Potassium and magnesium levels within normal limits. If below the lower limit of normal, must have levels corrected by supplementation prior to starting study drug. viii. albumin > 3.0 g/dL
Serum magnesium > 1.2mEq/L
Serum magnesium must be within institutional normal limits
Renal function: Serum creatinine ? 1.5 x ULN or 24-hour clearance ? 40 ml/min, Serum potassium, magnesium and calcium must be within normal limits
Serum calcium, magnesium and potassium must be within normal limits; supplementation to achieve normal values is permitted
Magnesium within normal limits (supplementation allowed)
Participants with a calcium/magnesium intake ratio > 2.6
Magnesium below the normal range despite supplementation, or above the CTCAE grade 1 upper limit
Serum potassium, calcium, magnesium, phosphorus within normal limits (may be supplemented)
Serum magnesium and corrected serum calcium within the institution’s normal reference range
The patient has serum electrolytes (including calcium, magnesium, phosphorous, sodium and potassium) within normal limits (supplementation to maintain normal electrolytes is allowed).