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| Tracking Information | |||||
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| First Received Date ICMJE | October 3, 2002 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | November 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Event free survival at day 14 (myeloid engraftment) [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Event free survival at day 14 (myeloid engraftment) | ||||
| Change History | Complete list of historical versions of study NCT00047021 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma | ||||
| Official Title ICMJE | A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients receive high-dose cytarabine IV over 1 hour on days 1-5 and high-dose mitoxantrone IV over 15-30 minutes on day 5. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover. Patients who achieve at least stable disease or a response may receive a second course beginning at least 14 days after the first course is completed. Patients are followed for 3 months. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within approximately 2-3 years. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | up to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00047021 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000257234, CWRU-5Y01, NCI-G02-2113, CWRU-11021P, CASE-5Y01 | ||||
| Study Sponsor ICMJE | Ireland Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2006 | ||||
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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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