What side effects are associated with this type of intervention?

Common treatments for solid tumors that inhibit DNA repair mechanisms, such as PARP inhibitors and DNA-damaging agents, often lead to side effects including anemia, thrombocytopenia, and neutropenia due to bone marrow suppression. Patients may also experience gastrointestinal symptoms like nausea, vomiting, and diarrhea, as well as fatigue and increased susceptibility to infections. Specific to DNA repair inhibitors, there can be additional risks of secondary cancers and cardiotoxicity. These side effects necessitate careful monitoring and supportive care during treatment.

What prior FDA approvals exist?

Several FDA-approved treatments for solid tumors target DNA repair mechanisms. PARP inhibitors such as olaparib, rucaparib, and niraparib are notable examples. These drugs inhibit the PARP enzyme, which is crucial for repairing single-strand DNA breaks, leading to cancer cell death, particularly in tumors with BRCA1/2 mutations. These treatments are used for ovarian, breast, and prostate cancers, among others. Similar to Novobiocin, these drugs exploit the inability of cancer cells to repair DNA damage effectively, thereby promoting cell death.

What other types of research exist?

Promising alternatives to Novobiocin for solid tumors include: 1) PARP inhibitors (e.g., Olaparib, Rucaparib) which inhibit DNA repair in BRCA-mutated cancers, 2) Checkpoint inhibitors (e.g., Pembrolizumab, Nivolumab) which enhance immune response against tumors, and 3) Topoisomerase I inhibitors (e.g., BN80915) which cause DNA strand breaks and have shown potent anticancer activity.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

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

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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 patient A 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.