← Back to Search

Proteasome Inhibitor; Purine Analog

Bortezomib + Clofarabine for Cancer

Phase 1

Recruiting

Led By Alice P Chen, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years

ECOG performance status less than or equal to 2

Must not have

Pregnant women, breastfeeding women, and HIV-positive patients on combination antiretroviral therapy

Active brain metastases, CNS disease, or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, cycle 1 day 1, and cycle 2 day 4/day 5

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and efficacy of the drug combination of bortezomib and clofarabine to treat cancer.

Who is the study for?

Adults over 18 with advanced cancer that's worsened after standard treatment or lacks effective therapy can join. They need normal organ/marrow function, a life expectancy over 3 months, and must use contraception. Excluded are pregnant/breastfeeding women, those with certain heart conditions, uncontrolled illnesses, severe neuropathy, active brain metastases/CNS disease, or allergies to similar drugs.

What is being tested?

The trial tests the safety and effectiveness of combining Bortezomib and Clofarabine in treating solid tumors and lymphoma. Participants receive these drugs in cycles: Bortezomib by injection on days 1 & 4; Clofarabine intravenously on days 1-5. The study includes initial dose-safety testing followed by an expansion cohort for further evaluation.

What are the potential side effects?

Potential side effects include reactions at the injection site for Bortezomib and infusion-related reactions from Clofarabine. Both drugs may cause blood disorders (like low platelet counts), liver issues (elevated bilirubin levels), fatigue, digestive problems (nausea/vomiting), increased risk of infection due to lowered white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My cancer has not responded to standard treatments or there are no treatments available.

Select...

I finished my last cancer treatment at least 3 weeks ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, breastfeeding, or HIV-positive on antiretroviral therapy.

Select...

I do not have active brain tumors or cancer in my spinal fluid.

Select...

I do not have any serious illnesses that would stop me from following the study's requirements.

Select...

I have moderate to severe numbness, tingling, or muscle weakness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, cycle 1 day 1, and cycle 2 day 4/day 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, cycle 1 day 1, and cycle 2 day 4/day 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, cycle 1 day 1, and cycle 2 day 4/day 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and MTD

Secondary study objectives

Biomarkers of DNA damage and apoptosis in circulating tumor cells

Biomarkers of cell death and DNA damage in tumor biopsy tissue

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

Starting doses are clofarabine at 1 mg/m2 IV on days 1 through 5 of a 21-day cycle, and bortezomib at 0.8 mg/m2 subcutaneously on days 1 and 4 of a 21-day cycle.

0 / 8Eligibility criteria met