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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-00136 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy, such as dexrazoxane and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may help kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of dexrazoxane when given together with cisplatin in treating patients with advanced solid tumors.
OBJECTIVES:
OUTLINE: Patients receive dexrazoxane hydrochloride IV continuously over 96 hours beginning on day 1 and cisplatin IV over 1 hour on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood is collected periodically during course one for pharmacokinetic studies. DNA isolated from the samples is also analyzed for oxidative DNA damage by gas chromatography/mass spectrometry.
After completion of study treatment, patients are followed periodically.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| dexrazoxane hydrochloride | Drug | |||
| high performance liquid chromatography | Other | |||
| laboratory biomarker analysis | Other | |||
| mass spectrometry | Other | |||
| pharmacological study | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | ||
| Maximum tolerated dose of dexrazoxane hydrochloride and cisplatin |
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DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically confirmed advanced, incurable cancer that is unresponsive to prior chemotherapy regimens or for which no standard chemotherapy regimen exists
History of brain metastases allowed if controlled by radiotherapy or surgery and patient's neurological status is stable
Not eligible for a higher priority study
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen I. Shibata, MD | City of Hope Medical Center | Study Chair |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D064730 | Dexrazoxane |
| D002851 | Chromatography, High Pressure Liquid |
| D013058 | Mass Spectrometry |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011929 | Razoxane |
| D054659 | Diketopiperazines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002853 | Chromatography, Liquid |
| D002845 | Chromatography |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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