Trial of the Combination of Bortezomib and Clofarabine in Adults With Relapsed Solid Tumors | Aplastic Anemia and MDS International Foundation

ClinicalTrials.gov Identifier:

NCT0211755

Company

National Cancer Institute

Contact Info

Clinical Trial Coordinator/Contact Person

Debbie Childs: debbie.childs@nih.gov

240-781-4013

Dates

Start: August 2014
End: August 2018

Official Title

Trial of the Combination of Bortezomib and Clofarabine in Adults With Relapsed Solid Tumors

Purpose

This is an open-label Phase I trial.

The starting dose of clofarabine will be 1 mg/m2 administered intravenously on days 1 through 5 of a 21-day cycle; bortezomib will be administered at 0.8 mg/m2 subcutaneously on days 1 and 4 of a 21-day cycle.

Dose escalation will follow a 3+3 design, with dose limiting toxicities defined during cycle 1.

Dose escalation will proceed in cohorts comprised of two separate groups of patients (one group of patients with solid tumor/lymphoma and one group of patients with MDS), with at least 1 from each group, until hematologic DLT or the second grade 2 hematologic toxicity is observed, at which point, dose escalation will proceed separately for two cohorts: (1) patients with solid tumors/lymphoma and (2) patients with MDS.

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Recruiting
Phase: 
Phase 1
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
Inclusion Criteria: 
  • Study participants must have histologically confirmed solid tumors or lymphomas or myelodysplastic syndromes that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist
  • Age greater than or equal to 18
  • No major surgery, radiation, or chemotherapy within 3 weeks prior to entering the study
  • Adequate organ function

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