Arsenic Trioxide and Pamidronate in Treating Patients With Advanced Solid Tumors or Multiple Myeloma

Completed · Phase 1

Conditions studied: Refractory Multiple Myeloma, Unspecified Adult Solid Tumor, Protocol Specific

In brief

Drugs used in chemotherapy, such as arsenic trioxide and pamidronate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Arsenic trioxide and pamidronate may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pamidronate may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving arsenic trioxide together with pamidronate may kill more cancer cells. This phase I trial is studying the side effects and best dose of arsenic trioxide and pamidronate in treating patients with advanced solid tumors or multiple myeloma

Key facts

Study ID: NCT00124605
Run by: National Cancer Institute (NCI)
People needed: 24
Starts: 2005-04-01
Last updated by the study team: 2013-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

City of Hope — Duarte, California, United States

Full record on ClinicalTrials.gov

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