Arsenic Trioxide and Pamidronate in Treating Patients With Advanced Solid Tumors or Multiple Myeloma
Phase I Trial of Arsenic Trioxide in Combination With Pamidronate Disodium
4 other identifiers
interventional
24
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 26, 2005
CompletedFirst Posted
Study publicly available on registry
July 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedJanuary 7, 2013
January 1, 2013
4.2 years
July 26, 2005
January 4, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
MTD defined as the highest dose tested in which greater than 33% of patients experienced dose limiting toxicity (DLT) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
The toxicities observed at each dose level will be summarized in terms of type, severity, time of onset, duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course. Tabular and graphical summaries will be used to explore the relationship of type and grade of toxicity to dose, course, and pharmacokinetics.
28 days
Secondary Outcomes (2)
Survival
Up to 4 years
Time to failure
Up to 4 years
Study Arms (1)
Treatment (pamidronate disodium and arsenic trioxide)
EXPERIMENTALPatients receive pamidronate IV and over 2 hours on days 1 and 15 and arsenic trioxide IV over 2 hours on days 1-5 and 15-19. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Correlative studies
Correlative studies
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
City of Hope
Duarte, California, 91010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Przemyslaw Twardowski
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2005
First Posted
July 28, 2005
Study Start
April 1, 2005
Primary Completion
June 1, 2009
Last Updated
January 7, 2013
Record last verified: 2013-01