COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: \- Researchers want to develop better ways to treat cancer. In this study, they will give people with cancer two drugs. These drugs have been used on their own to treat some blood cell cancers. Objectives: \- To test the safety and efficacy of the drug combination of bortezomib and clofarabine. Eligibility: \- Adults age 18 and over with advanced cancer that has progressed after receiving standard treatment or that has no effective therapy. Design: * Participants will be screened with medical history, physical exam, and scans to measure their tumors. They will also have heart, blood, and urine tests. All of these may be done by their regular doctors. * Participants will get the study drugs in 21-day cyles. They will stay at the clinic for week 1 of every cycle, then have 2 weeks off. \<TAB\>- Bortezomib will be injected under the skin on days 1 and 4. \<TAB\>- Clofarabine will be injected in a vein for days 1-5. * During cycle 1 only, participants will go to the clinic or their doctor to have a physical exam and blood tests at the start of the second and third week. * Participants will have clinical evaluations throughout the study, including before receiving treatment and then before the start of each cycle. * Participants may stay in the study as long as they are tolerating the drugs and their tumor is not getting worse. * Participants will have follow-up for 30 days after the last dose of study drugs. * The first part of this study tests the safety of different doses of clofarabine and bortezomib. * The second part of this study involves a separate group of participants who will undergo mandatory research biopsies to learn more about the effects of clofarabine and bortezomib on cancer cells.

Official Title

Phase I Trial of the Combination of Bortezomib and Clofarabine in Adults With Refractory Solid Tumors, Lymphomas, or Myelodysplastic Syndromes

Quick Facts

Study Start:2014-10-06
Study Completion:2025-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT02211755

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Alice P Chen, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Alice P Chen, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-10-06
Study Completion Date2025-08-15

Study Record Updates

Study Start Date2014-10-06
Study Completion Date2025-08-15

Terms related to this study

Keywords Provided by Researchers

  • Purine Nucleoside Inhibitor
  • Proteasome Inhibitor
  • Combination Treatment
  • Solid Tumors
  • Hematologic

Additional Relevant MeSH Terms

  • Neoplasms
  • Myelodysplastic Syndromes
  • Lymphomas