Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma
This study has been completed.
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00047021
First received: October 3, 2002
Last updated: June 10, 2010
Last verified: June 2010
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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 2 |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Myeloid Leukemia
Leukemia
Lymphoma
U.S. FDA Resources
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- Event free survival at day 14 (myeloid engraftment) [ Time Frame: day 14 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment [ Time Frame: followed for 3 months ] [ Designated as safety issue: No ]
| 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) |
Intervention Details:
Detailed Description:
-
Biological: sargramostim
Sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.
Drug: cytarabine
high-dose cytarabine IV over 1 hour on days 1-5
Drug: mitoxantrone hydrochloride
high-dose mitoxantrone IV over 15-30 minutes on day 5.
OBJECTIVES:
- Determine non-hematologic toxic effects of high-dose cytarabine and high-dose mitoxantrone in patients with recurrent or refractory leukemia or lymphoma.
- Determine the in vitro T/NK lymphocyte proliferative responses to patient's leukemia/lymphoma cells before and after treatment with this regimen.
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 |
Criteria
DISEASE CHARACTERISTICS:
One of the following must be present:
Histologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia
- More than 5% blasts in the bone marrow or peripheral blood unrelated to recovery of normal hematopoiesis from prior chemotherapy
- Failed at least 1 attempt at induction chemotherapy
Diagnosis of non-Hodgkin's lymphoma or Hodgkin's lymphoma
- Refractory or relapsed after at least 1 regimen of standard chemotherapy
Diagnosis of chronic myelogenous leukemia in accelerated phase or blast crisis
- Received at least 1 myelotoxic chemotherapy regimen
- Active CNS involvement allowed
PATIENT CHARACTERISTICS:
Age
- 55 and under
Performance status
- ECOG 0-2
Life expectancy
- At least 5 weeks
Hematopoietic
Lymphoma patients:
- WBC at least 2,000/mm^3*
- Platelet count at least 20,000/mm^3* NOTE: *Unless due to bone marrow involvement or disease process
Hepatic
- Bilirubin no greater than 3 times normal*
- AST/ALT no greater than 3 times normal*
- Alkaline phosphatase no greater than 3 times normal*
- No severe liver failure NOTE: *Unless related to leukemia
Renal
- Creatinine clearance greater than 50 mL/min
- No severe renal failure
Cardiovascular
- LVEF at least 45% by MUGA
Pulmonary
- DLCO at least 60% of predicted
Other
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychiatric illness that would preclude informed consent
- No medical illness or other condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- At least 24 hours since prior hydroxyurea
- At least 1 week since other prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- Recovered from prior therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047021
Locations
| United States, Ohio | |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-7284 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Principal Investigator: | Mary J. Laughlin, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| 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 |
Keywords provided by Case Comprehensive Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 21, 2013