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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CWRU-5Y01 | |||
| NCI-G02-2113 | |||
| CWRU-11021P | |||
| CASE-5Y01 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sargramostim | Biological | Sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover. | ||
| cytarabine | Drug | high-dose cytarabine IV over 1 hour on days 1-5 | ||
| mitoxantrone hydrochloride | Drug | high-dose mitoxantrone IV over 15-30 minutes on day 5. |
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival at day 14 (myeloid engraftment) | day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment | followed for 3 months |
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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
Active CNS involvement allowed
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
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| Name | Affiliation | Role |
|---|---|---|
| Mary J. Laughlin, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-7284 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D001752 | Blast Crisis |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D002051 | Burkitt Lymphoma |
| D006689 | Hodgkin Disease |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D012008 | Recurrence |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D015451 |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C081222 | sargramostim |
| D003561 | Cytarabine |
| D008942 | Mitoxantrone |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Leukemia, Lymphocytic, Chronic, B-Cell |
| D000013 | Congenital Abnormalities |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D007945 | Leukemia, Lymphoid |
| D016393 | Lymphoma, B-Cell |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D015448 | Leukemia, B-Cell |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |