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Clofarabine in Adult Patients With Advanced Solid Tumors

NCT00125840 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-02-05

No results posted yet for this study

Summary

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.

This research study of clofarabine will be used for advanced cancer in persons in which drugs are no longer effective or no reliable effective treatment is available. The purpose of this study is to find the answers to the following research questions:

1. What is the largest dose of clofarabine that can be safely administered as an IV infusion (over at least 2 hours) once a week for 3 weeks (days 1, 8 and 15) followed by 1 week of rest and repeated every 28 days?
2. What are the side effects of clofarabine when given on this schedule?
3. How much clofarabine is in the blood at specific times after administration and how does the body get rid of the drug? Once the MTD/RP2D is established, patients will be enrolled at the MTD/RP2D regardless of the PK data with cardiac assessments done every other cycle.
4. Will clofarabine help treat a specific cancer?

Conditions

  • Solid Tumors
  • Leukemia, Lymphocytic, Acute, Pediatric
  • Leukemia, Lymphocytic, Acute, Adult
  • Leukemia, Myelocytic, Acute, Pediatric
  • Leukemia, Myelocytic, Acute, Adult
  • Myelodysplastic Syndromes, Adult

Interventions

DRUG

clofarabine (IV formulation)

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00125840 on ClinicalTrials.gov