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Antibiotic
Novobiocin for Cancer
Phase 1
Recruiting
Led By Geoffrey I Shapiro
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests novobiocin, an antibiotic, in cancer patients with specific DNA repair gene mutations who haven't responded to other treatments. Novobiocin blocks a protein that helps cancer cells repair themselves, leading to their death. Studies show that novobiocin can make other cancer treatments more effective.
Who is the study for?
This trial is for adults with advanced or inoperable tumors that have specific mutations in DNA repair genes. Patients must have tried other treatments without success and may or may not have used PARP inhibitors, depending on the type of cancer. They should be relatively healthy otherwise, with adequate blood cell counts and organ function.
What is being tested?
The trial is testing Novobiocin Sodium's safety and optimal dosage. It's an antibiotic thought to kill cancer cells by blocking a protein involved in DNA repair. The study includes biopsies, biospecimen collection, and diagnostic imaging to monitor effects.
What are the potential side effects?
While the side effects of Novobiocin are being studied here, potential risks might include typical drug reactions like nausea, allergic responses, changes in blood pressure or heart rate, liver toxicity, fatigue or discomfort at injection sites.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose (MTD) and recommended phase 2 dose of continuous novobiocin administration
Secondary study objectives
Biological effectiveness
Plasma concentrations of novobiocin
Other study objectives
ATM immunohistochemistry (IHC)
POLQ messenger ribonucleic acid level (mRNA)
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: Treatment (novobiocin sodium)Experimental Treatment4 Interventions
Patients receive novobiocin sodium PO QD for 5 days in a row followed by 2 days off each week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy at baseline, on day 15 of cycle 1, and at time of progression. Patients undergo medical imaging scans at baseline and every 8 weeks. Patients also undergo blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Biopsy
2014
Completed Phase 4
~1090
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for solid tumors include chemotherapy, radiation therapy, and immunotherapy, each targeting cancer cells through different mechanisms. Chemotherapy often works by damaging the DNA of rapidly dividing cells, leading to cell death.
Radiation therapy similarly damages DNA but uses high-energy particles or waves. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells.
Treatments like Novobiocin, which inhibit DNA polymerase theta, prevent cancer cells from repairing their damaged DNA, leading to cell death. This is particularly important for solid tumor patients as it targets the cancer cells' ability to survive and proliferate, potentially leading to more effective treatments and better outcomes.
Efficacy of carboplatin chemotherapy in a metastatic, castration-resistant BRCA2 mutation positive prostate cancer patientA Case of Therapy-Related Acute Myeloid Leukemia in a Patient With Heterozygous Mutations in the Ataxia Telangiectasia Mutated Gene.Neoadjuvant Chemotherapy Considerations in Triple-Negative Breast Cancer.
Efficacy of carboplatin chemotherapy in a metastatic, castration-resistant BRCA2 mutation positive prostate cancer patientA Case of Therapy-Related Acute Myeloid Leukemia in a Patient With Heterozygous Mutations in the Ataxia Telangiectasia Mutated Gene.Neoadjuvant Chemotherapy Considerations in Triple-Negative Breast Cancer.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,016,768 Total Patients Enrolled
Geoffrey I ShapiroPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
3 Previous Clinical Trials
320 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Treatment (novobiocin sodium)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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