Arsenic Trioxide in Treating Patients With Advanced Hematologic Cancer
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| ClinicalTrials.gov Identifier: NCT00003395 |
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Recruitment Status :
Completed
First Posted : August 16, 2004
Last Update Posted : June 25, 2013
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| Tracking Information | ||||
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| First Submitted Date ICMJE | November 1, 1999 | |||
| First Posted Date ICMJE | August 16, 2004 | |||
| Last Update Posted Date | June 25, 2013 | |||
| Study Start Date ICMJE | April 1998 | |||
| Actual Primary Completion Date | March 2000 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE | Not Provided | |||
| Original Primary Outcome Measures ICMJE | Not Provided | |||
| Change History | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Pre-specified Outcome Measures | Not Provided | |||
| Original Other Pre-specified Outcome Measures | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Arsenic Trioxide in Treating Patients With Advanced Hematologic Cancer | |||
| Official Title ICMJE | Dose-Ranging Study of Arsenic Trioxide in Advanced Hematologic Cancers | |||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of arsenic trioxide in treating patients who have advanced hematologic cancer. |
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| Detailed Description | OBJECTIVES: I. Develop a safe, weight-based, extended-dosing regimen of arsenic trioxide suitable for outpatient therapy in patients with advanced hematologic cancers. II. Determine the pattern of clinical adverse experience in patients treated with this drug. III. Evaluate evidence of clinical responsiveness that may provide leads for further testing in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive arsenic trioxide IV over 1-4 hours on days 1-25. Courses repeat every 3-5 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. Patients are followed for 1 month. PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study. |
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| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Primary Purpose: Treatment | |||
| Condition ICMJE |
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| Intervention ICMJE | Drug: arsenic trioxide | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | Not Provided | |||
| Original Enrollment ICMJE | Not Provided | |||
| Actual Study Completion Date ICMJE | March 2000 | |||
| Actual Primary Completion Date | March 2000 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically proven hematologic cancer, including acute or chronic leukemia, malignant lymphoma, or multiple myeloma Exclude acute promyelocytic leukemia (M3) Relapse from or resistance to at least one course of standard anticancer therapy and lack of alternative therapy that has proven to be curative in the underlying disease PATIENT CHARACTERISTICS: Age: 17 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.5 mg/dL Renal: Creatinine no greater than 2.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception during and for at least 4 months after study No history of grand mal seizures (other than infantile febrile seizures) No active serious infections that are not controlled by antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 17 Years and older (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00003395 | |||
| Other Study ID Numbers ICMJE | 98-023 CDR0000066395 ( Registry Identifier: PDQ (Physician Data Query) ) NCI-G98-1449 |
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| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | |||
| Collaborators ICMJE | National Cancer Institute (NCI) | |||
| Investigators ICMJE |
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| PRS Account | Memorial Sloan Kettering Cancer Center | |||
| Verification Date | June 2013 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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