Gleostine (Lomustine)

Brand Name

Gleostine

Generic Name

Lomustine

View Brand Information

FDA approval date: August 18, 2014

Classification: Alkylating Drug

Form: Capsule

What is Gleostine (Lomustine)?

Gleostine is an alkylating drug indicated for the treatment of patients with: Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy.

Approved To Treat

Top Global Experts

View All

Save this treatment for later

Not sure about your diagnosis?

Check Your Symptoms

Tired of the same old research?

Check Latest Advances

Related Clinical Trials

Randomized Phase II Trial of Anti-Lag-3 and Anti-PD-1 Blockade vs. SOC in Patients With Recurrent Glioblastoma

Enrollment Status: Recruiting

Publish Date: October 15, 2025

Intervention Type: Procedure, Biological, Drug

Study Phase: Phase 2

Summary: This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlimab) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibo...

A Phase 1 Safety and Feasibility Study of Laser Interstitial Thermal Therapy (LITT) Followed by Lomustine (CCNU) for Recurrent Glioblastoma in Adults

Enrollment Status: Recruiting

Publish Date: October 09, 2025

Intervention Type: Drug, Procedure

Study Phase: Phase 1

Summary: This is a phase 1 study evaluating the safety and feasibility of laser interstitial thermal therapy (LITT) followed by lomustine (CCNU) for recurrent glioblastoma in adults. The primary aim is to evaluate the safety of the combination of LITT plus lomustine based on the assessment of treatment-related adverse events and the feasibility of completing LITT + lomustine in the proposed timeframe. The ...

A Prospective, Multicenter, Randomized Controlled Study Comparing Venetoclax-Enhanced BUCY With Standard BUCY Conditioning in High-Risk AML and MDS Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Enrollment Status: Recruiting

Publish Date: September 19, 2025

Intervention Type: Drug, Other

Study Phase: Not Applicable

Summary: This is a prospective, multicenter, randomized controlled trial designed to evaluate the efficacy and safety of venetoclax-enhanced BUCY (Ven-BUCY) conditioning compared to the standard BUCY regimen in patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Eligible participants aged 12 to 60...

View All Clinical Trials

Related Latest Advances

Analysis of Anticancer Drugs Used to Treat Brain Cancer Using the Cheapest and Costliest Drugs in India: A Cost-comparison Health Economics Study.

Journal: The Journal of the Association of Physicians of India

Published: October 16, 2025

Incidence, management, and outcomes of procarbazine-associated hypersensitivity reactions in patients receiving PCV for lower-grade gliomas.

Journal: Neuro-oncology practice

Published: October 13, 2025

Reirradiation in recurrent glioblastoma.

Journal: Current opinion in oncology

Published: October 07, 2025

View All Latest Advances

Brand Information

Gleostine (lomustine)

WARNING: DELAYED MYELOSUPPRESSION and RISK OF OVERDOSAGE

DELAYED MYELOSUPPRESSION

Gleostine causes myelosuppression including fatal myelosuppression. Myelosuppression is delayed, dose-related, and cumulative; occurring 4 to 6 weeks after drug administration and persisting for 1 to 2 weeks. Thrombocytopenia is generally more severe than leukopenia. Cumulative myelosuppression from Gleostine is manifested by greater severity and longer duration of cytopenias. Monitor blood counts for at least 6 weeks after each dose. Do not give Gleostine more frequently than every 6 weeks .

RISK OF OVERDOSAGE

PRESCRIBE, DISPENSE, AND ADMINISTER ONLY ENOUGH CAPSULES FOR ONE DOSE. Fatal toxicity occurs with overdosage of Gleostine. Both physician and pharmacist should emphasize to the patient that only one dose of Gleostine is taken every 6 weeks .

1DOSAGE FORMS AND STRENGTHS

Gleostine capsules are available in three strengths, distinguishable by the color of the capsules:

100 mg capsules (green/green)
40 mg capsules (white/green)
10 mg capsules (white/white)

2CONTRAINDICATIONS

None.

3ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

Delayed myelosuppression
Risks of overdosage
Pulmonary toxicity
Secondary malignancies
Hepatotoxicity
Nephrotoxicity

The following adverse reactions associated with the use of Gleostine were identified in clinical trials or postmarketing reports. Because these reactions were reported from a population of uncertain size, it is not possible to estimate their frequency, reliability, or establish a causal relationship to drug exposure.

Gastrointestinal disorders:nausea, vomiting, and stomatitis

Ocular disorders:optic atrophy, visual disturbances, and blindness

Neurologic disorders:disorientation, lethargy, ataxia, and dysarthria

Other:alopecia

4OVERDOSAGE

Overdosage with Gleostine has occurred, including fatal cases

No antidotes exist for Gleostine overdosage.

5DESCRIPTION

Gleostine (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C

The chemical structure is:

Gleostine is supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2.

6REFERENCES

OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.