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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 November 2012 |
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Main ID: |
NCT00124605 |
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Date of registration:
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26/07/2005 |
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Primary sponsor: |
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Public title:
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Arsenic Trioxide and Pamidronate in Treating Patients With Advanced Solid Tumors or Multiple Myeloma
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Scientific title:
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Phase I Trial of Arsenic Trioxide in Combination With Pamidronate |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00124605 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Przemyslaw W. Twardowski, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beckman Research Institute |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed solid tumors or multiple myeloma
- Advanced disease
- Refractory to standard therapy OR no standard therapy exists
- Brain metastases allowed provided they are controlled and patient does not require
treatment with corticosteroids
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- WHO 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 75,000/mm^3
Hepatic
- Bilirubin = 1.5 times upper limit of normal (ULN)
- AST and ALT = 2.5 times ULN
Renal
- Creatinine clearance > 50 mL/min
Cardiovascular
- QT interval = 460 msec by ECG AND potassium normal AND magnesium normal
- No history of torsades de pointes-type ventricular arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of hypersensitivity to pamidronate or other bisphosphonates
- No uncontrolled electrolyte imbalance, including any of the following:
- Sodium < 132 mmol/L
- Potassium < 3.5 mmol/L
- Magnesium < 1.7 mg/dL
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered
- No prior arsenic trioxide
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- More than 3 weeks since prior radiotherapy and recovered
Surgery
- Not specified
Other
- Recovered from prior investigational agents.
- At least 28 days since prior pamidronate or other bisphosphonates.
- No other concurrent bisphosphonates
- No other concurrent antineoplastic therapy
- No concurrent drugs known to prolong the QT interval
- No other concurrent investigational agents
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Myeloma and Plasma Cell Neoplasm
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Unspecified Adult Solid Tumor, Protocol Specific
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Intervention(s)
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Drug: arsenic trioxide
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Drug: pamidronate disodium
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Secondary ID(s)
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CCC-PHI-45
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CDR0000434807
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NCI-6458
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U01CA062505
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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