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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00546377 |
RATIONALE: Pentostatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread.
Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving pentostatin together with combination chemotherapy and rituximab may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of mitoxantrone when given together with pentostatin, cyclophosphamide, and rituximab and to see how well it works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell cancer.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Biological: filgrastim Biological: pegfilgrastim Biological: rituximab Biological: sargramostim Drug: cyclophosphamide Drug: mitoxantrone hydrochloride Drug: pentostatin Genetic: fluorescence in situ hybridization Genetic: gene rearrangement analysis Genetic: polymerase chain reaction Genetic: protein expression analysis Other: flow cytometry Procedure: biopsy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I-II Study of Pentostatin, Cyclophosphamide, Rituximab, and Mitoxantrone in Previously Treated Patients With Chronic Lymphocytic Leukemia and Other Low Grade B-Cell Neoplasms |
Estimated Enrollment: | 63 |
Study Start Date: | July 2005 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a phase I, dose-escalation study of mitoxantrone hydrochloride followed by a phase II study.
Phase I: Patients receive pentostatin IV, cyclophosphamide IV, and mitoxantrone hydrochloride IV on day 1. Patients also receive rituximab IV on day
1 beginning in course 2. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood collection and bone marrow biopsy periodically for assessment of therapy response by biomarker and laboratory studies. Samples are analyzed for molecular genetics for IgH arrangement by PCR and for response by immunoelectrophoresis. Some samples are analyzed for response by flow cytometry or fluorescence in situ hybridization (FISH).
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 63 patients (18 patients for phase I and 45 patients for phase II) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following diseases confirmed by a Memorial Sloan-Kettering Cancer Center (MSKCC) pathologist:
Chronic lymphocytic leukemia meeting the following risk criteria as defined by the three-stage Rai system:
Intermediate-risk disease meeting the following criteria for active disease as defined by the NCI Working Group:
Other low grade B-cell neoplasms, including any of the following:
Previously treated disease
However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Normal cardiac ejection fraction ≥ 50% (increased ejection fraction [at least 5% over rest]) required for study eligibility
No ongoing hepatitis B infection, specifically hepatitis B antigen or surface antigen positivity
PRIOR CONCURRENT THERAPY:
The following concurrent medications are allowed:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Nicole Lamanna, MD 212-639-2279 lamannan@mskcc.org |
Principal Investigator: | Nicole Lamanna, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Mark Adam Weiss, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Andrew D. Zelenetz, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Nicole Lamanna ) |
Study ID Numbers: | CDR0000570266, MSKCC-05077 |
Study First Received: | October 17, 2007 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00546377 History of Changes |
Health Authority: | Unspecified |
B-cell chronic lymphocytic leukemia Waldenstrom macroglobulinemia recurrent mantle cell lymphoma recurrent small lymphocytic lymphoma refractory chronic lymphocytic leukemia |
recurrent marginal zone lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
Leukemia, Lymphoid Pentostatin Immunologic Factors Lymphoma, Mantle-Cell Lymphoma, Follicular Mantle Cell Lymphoma Cyclophosphamide Follicular Lymphoma Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Analgesics Leukemia, B-cell, Chronic Lymphoma Alkylating Agents |
Immunoproliferative Disorders Rituximab Immunosuppressive Agents Recurrence Lymphatic Diseases Waldenstrom Macroglobulinemia Chronic Lymphocytic Leukemia Peripheral Nervous System Agents Mitoxantrone Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Leukemia, B-Cell Antirheumatic Agents |
Leukemia, Lymphoid Pentostatin Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Sensory System Agents Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Analgesics Lymphoma Alkylating Agents Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Rituximab Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Myeloablative Agonists Peripheral Nervous System Agents Mitoxantrone Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Leukemia, B-Cell Antirheumatic Agents |