Clinical Trials Directory

Trials / Completed

CompletedNCT01658319

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Case Comprehensive Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGfludarabine phosphateGiven IV
DRUGmethoxyamineGiven IV
OTHERlaboratory biomarker analysisCorrelative studies
OTHERpharmacological studyCorrelative studies
GENETICwestern blottingCorrelative studies
OTHERmass spectrometryCorrelative studies
GENETICDNA analysisCorrelative studies

Timeline

Start date
2011-05-01
Primary completion
2015-02-01
Completion
2015-05-01
First posted
2012-08-07
Last updated
2015-08-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01658319. Inclusion in this directory is not an endorsement.