Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT00124605
Eligibility Criteria:
Inclusion Criteria:
* Patients with histologically or cytologically proven diagnosis of solid tumors or multiple myeloma refractory to standard therapy or for which no satisfactory treatment exists at the time of enrollment
* Patient must be capable of understanding the nature of the trial and must give written informed consent
* Patients must have a WHO performance status of 0, 1, or 2
* Patients must have life expectancy of at least three months
* Absolute neutrophil count of \> 1x10\^9 /L
* Platelet count \> 75 x 10\^9 /L
* Calculated creatinine clearance of \> 50 mL/min
* Serum bilirubin =\< 1.5 x the institutional upper limit of normal
* SGOT (AST) and SGPT (ALT) must be =\< 2.5 x the institutional upper limit of normal
* All patients must be willing to use adequate contraception
* Patients with brain metastases which at the time of study enrollment are controlled and do not require treatment with corticosteroids are eligible
* Patients must not have a prolonged QT interval \> 460 milliseconds on baseline ECG in the presence of normal serum potassium and magnesium values; ECG must be obtained within 28 days prior to registration
* Patients must not be receiving or planning to receive drugs known to prolong the QT interval
* Patients previously or currently treated with pamidronate or other bisphosphonates are eligible after a wash-out period of 28 days; concurrent treatment with other bisphosphonates is not allowed
* Patients must not have a history of torsades de pointes type ventricular arrhythmia
Exclusion Criteria:
* Patients who have had radiotherapy or chemotherapy within three weeks (nitrosoureas or mitomycin C within six weeks) prior to anticipated first day of dosing; patients must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy
* Patients with uncontrolled electrolyte imbalance (NA \< 132 mmol/L; K \< 3.5 mmol/L; Mg \< 1.7 mg/dL)
* Patients undergoing therapy with other investigational agents; patients must have recovered from all acute effects of previously administered investigational agents and sufficient time must have elapsed since last administration to ensure the drug interactions not occur during this study
* Patients who are pregnant or breast-feeding will be excluded
* Patients with history of hypersensitivity to pamidronate or other bisphosphonates
* Patients previously treated with arsenic trioxide are not eligible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00124605
Study Brief:
Protocol Section:
NCT00124605