Mitomycins

Generic Name: Mitomycins

Brand Names: Jelmyto, Mitosol, Mutamycin

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₈N_₄O_₅

CAS Number: 50-07-7

Unique Ingredient Identifier: 50SG953SK6

Background: Mitomycin is an antineoplastic antibiotic first isolated by Japanese microbiologists in the 1950s from cultures of Streptomyces caespitosus. It is an alkylating agent that inhibits DNA synthesis (and, at higher concentrations, RNA and protein synthesis) by cross-linking the complementary strands of the DNA double helix. Few other antibiotics have been discovered that work via this alkylating mechanism, making mitomycin relatively unique in the space of microbiota-derived therapies.

Mitomycin's cross-linking activity has resulted in its approval for the treatment of a variety of cancers - the most recent of which is an April 2020 approval for its use in low-grade Upper Tract Urothelial Cancer (LG-UTUC) - as well as adjunctly to ab externo glaucoma surgeries.

Indication: For treatment of malignant neoplasm of lip, oral cavity, pharynx, digestive organs, peritoneum, female breast, and urinary bladder. Also used as an adjunct to ab externo glaucoma surgery. Mitomycin is also indicated as a pyelocalyceal solution for the treatment of adults with low-grade upper tract urothelial cancer (LG-UTUC).

Associated Conditions: Anal Cancer, Bladder Cancer, Breast Cancer, Carcinoma of the Head and Neck, Cervical Cancer, Gastric Adenocarcinoma, Mesothelioma, Non-Small Cell Lung Cancer (NSCLC), Pancreatic Adenocarcinoma, Ab externo surgery Glaucoma, Low-grade Upper Tract Urothelial Cancer (LG-UTUC)

Clinical Trials

A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer

Phase 3

Not yet recruiting

Conditions: Non-Muscle Invasive Bladder Neoplasms

Interventions: Drug: TAR-210
Drug: Mitomycin C
Drug: Gemcitabine

First Posted Date: 2025-04-09

Last Posted Date: 2025-04-27

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 220

Registration Number: NCT06919965

Efficacy of the Use of Neoadjuvant With/without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer

Phase 3

Not yet recruiting

Conditions: Locally Advanced Colorectal Cancer

Interventions: Drug: Mitomycin (MM)
Drug: FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
Procedure: Cytoreductive surgery

First Posted Date: 2025-01-20

Last Posted Date: 2025-01-20

Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

Target Recruit Count: 1083

Registration Number: NCT06783491

Locations: 🇪🇸
Hospital Universitario Reina Sofia, Cordoba, Córdoba, Spain

Chemoablation or Bladder Resection with Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer

Phase 4

Not yet recruiting

Conditions: Non-Muscle Invasive Bladder Cancer

Interventions: Drug: Mitomycin c

First Posted Date: 2025-01-17

Last Posted Date: 2025-01-20

Lead Sponsor: Jakob Kristian Jakobsen

Target Recruit Count: 272

Registration Number: NCT06781879

Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial

Phase 2

Recruiting

Conditions: Non-Muscle Invasive Bladder Urothelial Carcinoma
Stage I Bladder Cancer AJCC v8
Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma

Interventions: Procedure: Biospecimen Collection
Drug: Cisplatin
Procedure: Computed Tomography
Drug: Fluorouracil
Biological: Pembrolizumab
Drug: Gemcitabine
Procedure: Magnetic Resonance Imaging
Drug: Mitomycin
Other: Questionnaire Administration
Radiation: Radiation Therapy

First Posted Date: 2025-01-13

Last Posted Date: 2025-05-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 160

Registration Number: NCT06770582

Locations: 🇺🇸
Shaw Cancer Center, Edwards, Colorado, United States
🇺🇸
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
🇺🇸
Louisiana Hematology Oncology Associates LLC, Baton Rouge, Louisiana, United States

and more 20 locations

In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial

Phase 1

Recruiting

Conditions: Non-Muscle Invasive Bladder Carcinoma
Stage 0is Bladder Cancer AJCC v8
Stage 0a Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8

Interventions: Biological: BCG Solution
Procedure: Cystoscopy
Drug: Docetaxel
Drug: Gemcitabine
Other: Home Health Encounter
Drug: Mitomycin
Other: Questionnaire Administration

First Posted Date: 2024-11-26

Last Posted Date: 2025-04-27

Lead Sponsor: Mayo Clinic

Target Recruit Count: 40

Registration Number: NCT06704191

Locations: 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

Investigating the Efficacy and Safety of Neoadjuvant Intravesical Instillation of Mitomycin C in Treating High-risk NMIBC Patients

Phase 3

Recruiting

Conditions: Non-Muscle-Invasive Bladder Cancer (NMIBC)

Interventions: Drug: Mitomycin C (MMC)
Drug: Normal Saline (Placebo)

First Posted Date: 2024-11-20

Last Posted Date: 2025-02-19

Lead Sponsor: Shaogang Wang

Target Recruit Count: 180

Registration Number: NCT06696794

Locations: 🇨🇳
The central Hospital of wuhan, Wuhan, Hubei, China
🇨🇳
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
🇨🇳
Xiangyang Central Hospital, Xiangyang, Hubei, China