Trial of the Combination of Bortezomib and Clofarabine in Adults With Relapsed Solid Tumors
Status:
Recruiting
Trial end date:
2023-06-02
Target enrollment:
Participant gender:
Summary
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.
- Bortezomib will be injected under the skin on days 1 and 4.
- 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.