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Methoxyamine and Fludarabine Phosphate in Treating Patients With Relapsed or Refractory Hematologic Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Methoxyamine and Fludarabine Phosphate in Treating Patients With Relapsed or Refractory Hematologic Malignancies

Phase I Trial of Fludarabine and Methoxyamine (TRC102) for Relapsed or Refractory Hematologic Malignancies

NCT01658319•Case Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

This phase I trial is studying the side effects and best dose of methoxyamine when given together with fludarabine phosphate in treating patients with relapsed or refractory hematologic malignancies. Drugs used in chemotherapy, such as methoxyamine and fludarabine phosphate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving methoxyamine together with fludarabine phosphate may kill more cancer cells.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of methoxyamine given in conjunction with fludarabine (fludarabine phosphate) in subjects with relapsed or refractory hematologic malignancies. SECONDARY OBJECTIVES: I. To determine the dose limiting toxicities of the combination of methoxyamine and fludarabine. II. To determine the pharmacokinetics of methoxyamine when given in combination with fludarabine. III. To evaluate pharmacodynamic endpoints including apurinic/apyrimidinic (AP) sites and deoxyribonucleic acid (DNA) strand breaks in blood mononuclear cells to explore the in vivo mechanism of action of methoxyamine and identify the biologically optimal dose to be combined with fludarabine. VI. To determine the disease specific toxicity and biologic activity in a cohort of chronic lymphocytic leukemia (CLL) patients. OUTLINE: This is a dose-escalation study of methoxyamine. Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days 1-5 and methoxyamine IV over 1 hour on day 1 (day 2 of course 1). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 1 year.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must have a histologically confirmed hematologic malignancy that has relapsed or proven refractory (in any time frame) to one or more prior therapies, limited to the following subtypes:
•* Non-Hodgkin lymphoma (NHL), including cutaneous lymphoma
•* Hodgkin lymphoma (HL)
•* Chronic lymphocytic leukemia (CLL)
•* Chronic myeloid leukemia (CML)
•* Multiple myeloma
•Patients must have progressed through standard curative treatment options in the case of NHL and HL or not be candidates for curative therapy
•Patients must have measurable disease, and must meet criteria justifying a need to initiate therapy, criteria for measurable disease and criteria for initiating therapy for purposes of this study are defined as follows:
•NHL/HL: measurable disease by radiographic criteria (\>= 1 cm by computed tomography); or any degree of bone marrow involvement with lymphoma by morphologic analysis; or measurable skin involvement according to cutaneous lymphoma response criteria; criteria for initiating therapy include aggressive histology (diffuse large B cell lymphoma, nodal T cell lymphomas, Hodgkin lymphoma) or presence of any of the following: systemic symptoms, bulk \>= 5 cm, \>= 3 nodal sites, marrow compromise remaining within limits of adequate function as defined below, splenomegaly \>= 16 cm, disease-related effusion, risk of local compressive symptoms, or circulating lymphoma cells
•CLL: measurable disease requires B lymphocytes equal or greater than 5,000/μL, or lymphadenopathy (\>= 1 cm by computed tomography), or bone marrow involvement of any degree; in addition, patients must have one of the following: Rai stage III (hemoglobin \< 11gm/dL) or IV (platelets \< 100,000/uL) disease, progressive splenomegaly, hepatomegaly or lymphadenopathy, weight loss \> 10% over the preceding 6 month period, grade 2 or 3 fatigue, fevers \> 100.5 or night sweats without evidence for infection, progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of \< 6 months
+13 more criteria

Exclusion Criteria

•Patients may not be receiving any other investigational agents or have received other investigational agents for at least 3 weeks
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Pregnant and lactating women are excluded from this study
•New York Heart Association (NYHA) classification III or IV heart disease
•Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
•Known seizure disorder
•Known human immunodeficiency virus (HIV) or chronic hepatitis (B or C) infection
•Patients unwilling or unable for any reason (personal, medical, or psychiatric) to comply with the protocol
•Patients with known hypersensitivity to fludarabine or a history of purine analog associated autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura

Locations (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Key Dates

Start Date

May 1, 2011

Primary Completion Date

February 1, 2015

Completion Date

May 1, 2015

Last Updated

August 13, 2015

Enrollment

ACTUAL participants

Conditions

Adult Nasal Type Extranodal NK/T-cell LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaCutaneous B-cell Non-Hodgkin LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaIntraocular LymphomaNodal Marginal Zone B-cell LymphomaPeripheral T-cell LymphomaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Mixed Cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Adult Immunoblastic Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Multiple MyelomaRelapsing Chronic Myelogenous LeukemiaSmall Intestine LymphomaSplenic Marginal Zone LymphomaStage III Chronic Lymphocytic LeukemiaTesticular LymphomaWaldenström Macroglobulinemia

Interventions

fludarabine phosphate

DRUG

methoxyamine

DRUG

laboratory biomarker analysis

OTHER

pharmacological study

OTHER

western blotting

GENETIC

mass spectrometry

OTHER

DNA analysis

GENETIC

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Methoxyamine and Fludarabine Phosphate in Treating Patients With Relapsed or Refractory Hematologic Malignancies

Inclusion Criteria

Exclusion Criteria

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