CompletedPhase 1

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

United States28 participantsStarted 2014-10-06

Plain-language 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. \<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.

Who can participate

Age range18 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients must have:
✓. Age greater than or equal to18 years.
✓. ECOG performance status less than or equal to 2.
✓. Life expectancy of greater than 3 months
✓. Patients must have normal organ and marrow function as defined below:
✓creatinine: ess than or equal to 1.5 X institutional ULN
✓. Bortezomib and clofarabine have both been assigned to pregnancy category D by the FDA. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for at least 3 months after dosing with study drugs ceases. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study drug administration.
✓. Patients must have completed any chemotherapy, radiation therapy, or biologic therapy \>= 3 weeks (or \>= 5 half-lives, whichever is shorter) prior to entering the study. Patients must be \>= 2 weeks since any prior administration of a study drug in a Phase 0 or equivalent study and be \>= 1 week from palliative radiation therapy (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI s discretion). Patients must have recovered to eligibility levels from prior toxicity or adverse events. Treatment with bisphosphonates is permitted.

What they're measuring

Safety and MTD

Timeframe: Cycle 1 (21 days)

Trial details

NCT IDNCT02211755

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-08-14

View on ClinicalTrials.gov More Neoplasms trials

Plain-language summary

Who can participate

Age range18 Years – 120 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Patients must have:
✓. Age greater than or equal to18 years.
✓. ECOG performance status less than or equal to 2.
✓. Life expectancy of greater than 3 months
✓. Patients must have normal organ and marrow function as defined below:
✓creatinine: ess than or equal to 1.5 X institutional ULN
✓. Bortezomib and clofarabine have both been assigned to pregnancy category D by the FDA. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for at least 3 months after dosing with study drugs ceases. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study drug administration.
✓. Patients must have completed any chemotherapy, radiation therapy, or biologic therapy \>= 3 weeks (or \>= 5 half-lives, whichever is shorter) prior to entering the study. Patients must be \>= 2 weeks since any prior administration of a study drug in a Phase 0 or equivalent study and be \>= 1 week from palliative radiation therapy (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI s discretion). Patients must have recovered to eligibility levels from prior toxicity or adverse events. Treatment with bisphosphonates is permitted.

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria