Studying the Safety and Determining the Optimal Dose of Novobiocin in Patients With Tumors That Have Alterations in DNA Repair Genes

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05687110
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Malignant Solid Neoplasm
  • Unresectable Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Diagnostic Imaging Testing — PROCEDURE
    Undergo medical imaging scans
  • Novobiocin Sodium — BIOLOGICAL
    Given PO

Study Details

This phase I trial tests the safety, side effects, and best dose of novobiocin in treating cancer patients with alterations in deoxyribonucleic acid (DNA) repair genes. Novobiocin is an antibiotic that blocks the activity of a protein called DNA polymerase theta, which helps repair DNA that has become damaged as cells grow and divide. Cancer cells that cannot repair their damaged DNA die. This medication may help shrink or stabilize cancer with a mutation in DNA repair genes.

Key Dates

Start date
Jul 6, 2023
Status verified
Apr 2026
Primary completion
Aug 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (novobiocin sodium)
    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 tumor biopsy, medical imaging scans, and collection of blood samples throughout the trial.

Primary Outcome Measure

Maximum tolerated dose (MTD) and recommended phase 2 dose of continuous novobiocin administration [ Time Frame: Up to 2 years ]

Locations (22)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010
Site Public Contact
[email protected]
800-826-4673
Sharonlin Bhardwaj (PRINCIPAL_INVESTIGATOR)
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvineCalifornia92612
Site Public Contact
[email protected]
877-827-8839
Jennifer B. Valerin (PRINCIPAL_INVESTIGATOR)
UC San Diego Moores Cancer CenterLa JollaCalifornia92093
Site Public Contact
[email protected]
858-822-5354
Shumei Kato (PRINCIPAL_INVESTIGATOR)
Los Angeles General Medical CenterLos AngelesCalifornia90033
Site Public Contact
[email protected]
323-865-0451
Varsha Tulpule (PRINCIPAL_INVESTIGATOR)
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Site Public Contact
323-865-0451
Varsha Tulpule (PRINCIPAL_INVESTIGATOR)
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Site Public Contact
[email protected]
877-827-8839
Jennifer B. Valerin (PRINCIPAL_INVESTIGATOR)
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Site Public Contact
916-734-3089
Nancy T. Nguyen (PRINCIPAL_INVESTIGATOR)
UC San Diego Medical Center - HillcrestSan DiegoCalifornia92103
Site Public Contact
[email protected]
Shumei Kato (PRINCIPAL_INVESTIGATOR)
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637
Site Public Contact
[email protected]
773-702-8222
Gini F. Fleming (PRINCIPAL_INVESTIGATOR)
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892
Site Public Contact
800-411-1222
A P. Chen (PRINCIPAL_INVESTIGATOR)
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Site Public Contact
617-667-9925
Gerburg M. Wulf (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Site Public Contact
877-442-3324
Geoffrey I. Shapiro (PRINCIPAL_INVESTIGATOR)
NYU Langone Hospital - Long IslandMineolaNew York11501
Site Public Contact
[email protected]
212-263-4432
Nancy Chan (PRINCIPAL_INVESTIGATOR)
Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew YorkNew York10016
Site Public Contact
[email protected]
Nancy Chan (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Site Public Contact
[email protected]
800-293-5066
John L. Hays (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
Site Public Contact
[email protected]
405-271-8777
Debra L. Richardson (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112
Site Public Contact
[email protected]
888-424-2100
Vaia Florou (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Site Public Contact
800-804-8824
Michael Schweizer (PRINCIPAL_INVESTIGATOR)
University of Washington Medical Center - MontlakeSeattleWashington98195
Site Public Contact
800-804-8824
Michael Schweizer (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadisonWisconsin53718
Site Public Contact
[email protected]
800-622-8922
Jeremy Kratz (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792
Site Public Contact
[email protected]
800-622-8922
Jeremy Kratz (PRINCIPAL_INVESTIGATOR)

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By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care· Irvine, CAUC San Diego Moores Cancer Center· La Jolla, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CA

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