Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2004-12-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental arm
Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab.
gemcitabine
900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
mitoxantrone
Novantrone 10 mg/m2on Day 1. The order of administration will be:
Gemzar--\>Novantrone--\>Rituxan.
rituximab
Rituxan 375 mg/m2 on Day 1. The order of administration will be:
Gemzar--\>Novantrone--\>Rituxan.
Interventions
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gemcitabine
900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
mitoxantrone
Novantrone 10 mg/m2on Day 1. The order of administration will be:
Gemzar--\>Novantrone--\>Rituxan.
rituximab
Rituxan 375 mg/m2 on Day 1. The order of administration will be:
Gemzar--\>Novantrone--\>Rituxan.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is CD20 positive (by immunohistochemistry or FACS)
* Is Cyclin D positive (by immunohistochemistry or FACS)
* Has received prior chemotherapy (required minimum of 1 prior therapies)
* Has received prior treatment with Rituxan
* Has an ECOG Performance Status (PS) 0-2
* Is greater than or equal to 18 years of age
* Has appropriate laboratory values (please refer to protocol for specific laboratory values)
* If a history of cardiac disease is indicated, patient has an LVEF greater than or equal to 50% (MUGA)
* Has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential)
* If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 2 months thereafter
* Has signed a Patient Informed Consent Form
* Has signed a Patient Authorization Form
Exclusion Criteria
* Has had prior treatment with Gemzar and/or Novantrone
* A history of known hypersensitivity to Gemzar, Novantrone, Rituxan, or any component of these drugs
* Has a history of hypersensitivity to murine-cell derived therapeutics
* Has a LVEF indicative of a cardiac condition (LVEF \< 50%)
* Is receiving concurrent immunotherapy
* Has evidence of CNS involvement
* Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
* Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
* Is a pregnant or nursing woman
* Is unable to comply with requirements of study
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
US Oncology Research
INDUSTRY
Responsible Party
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US Oncology Research
Principal Investigators
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Lawrence Garbo, MD
Role: PRINCIPAL_INVESTIGATOR
US Oncology Research
Other Identifiers
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04-026
Identifier Type: -
Identifier Source: org_study_id