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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00047021 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: sargramostim Drug: cytarabine Drug: mitoxantrone hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies |
| Enrollment: | 3 |
| Study Start Date: | November 2001 |
| Study Completion Date: | September 2005 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following must be present:
Histologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia
Diagnosis of non-Hodgkin's lymphoma or Hodgkin's lymphoma
Diagnosis of chronic myelogenous leukemia in accelerated phase or blast crisis
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Lymphoma patients:
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-7284 | |
| Principal Investigator: | Mary J. Laughlin, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
| Responsible Party: | Mary J. Laughlin, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00047021 History of Changes |
| Other Study ID Numbers: | CWRU5Y01, P30CA043703, CWRU-5Y01, NCI-G02-2113, CWRU-11021P, CASE-5Y01 |
| Study First Received: | October 3, 2002 |
| Last Updated: | June 10, 2010 |
| Health Authority: | United States: Federal Government |
|
accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma |
recurrent childhood small noncleaved cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent/refractory childhood Hodgkin lymphoma relapsing chronic myelogenous leukemia secondary acute myeloid leukemia childhood chronic myelogenous leukemia atypical chronic myeloid leukemia recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
|
Leukemia Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Mitoxantrone Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |