Temozolomide

Mycosis Fungoides, Advance Directives, Radiotherapy + 11 more

Treatment

20 Active Studies for Temozolomide

What is Temozolomide

Temozolomide

The Generic name of this drug

Treatment Summary

Temozolomide is a medication used to treat brain tumors such as refractory anaplastic astrocytoma (WHO grade III) and Glioblastoma multiforme (WHO grade IV). It is a prodrug that is taken orally or through injection, and it works by releasing a highly reactive methyl diazonium cation that leads to DNA damage and eventual cell death. Temozolomide is the standard of care for these types of tumors and was approved by the FDA in 1999 and 2009. It is marketed under the name TEMODAR® by Merck.

Temodar

is the brand name

image of different drug pills on a surface

Temozolomide Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Temodar

Temozolomide

1999

164

Effectiveness

How Temozolomide Affects Patients

Temozolomide is a drug that works by attacking and damaging DNA in cells, leading to their death. This drug can cause myelosuppression (lowered production of white and red blood cells), myelodysplastic syndrome, secondary malignancies, and myeloid leukemia. Pneumonia and liver damage are also possible side effects and patients must be monitored for these issues throughout their course of treatment. Animal studies have found that this drug can have serious effects on unborn babies, so male and female patients should use contraception for three and six months after their last dose.

How Temozolomide works in the body

Glioblastoma is a type of brain tumor treated with radiotherapy and chemotherapy, usually with a drug called temozolomide. Temozolomide is a small molecule that breaks down in the body to form an agent that can attach to the DNA in cancer cells. This agent specifically targets guanine in the DNA, which causes the cell to die or prevents it from reproducing. It can also alter the number of immune system cells in the tumor, which may enhance the effectiveness of immunotherapies.

When to interrupt dosage

The proposed dose of Temozolomide is contingent upon the diagnosed ailment, such as Refractory Ewing Sarcoma, melanoma and Glioblastoma. The quantity of dosage fluctuates, as per the method of administration (e.g. Capsule or Intravenous) featured in the table beneath.

Condition

Dosage

Administration

Disease Progression

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Advance Directives

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Glioblastoma

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Nitrosourea treatment

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Procarbazine treatment

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Sarcoma, Ewing

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Anaplastic astrocytoma

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Radiotherapy

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Mycosis Fungoides

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Advance Directives

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

melanoma

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Primary Central Nervous System Lymphoma (PCNSL)

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Soft Tissue Sarcoma

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Neuroblastoma

5.0 mg, , 20.0 mg, 100.0 mg, 250.0 mg, 140.0 mg, 180.0 mg, 2.5 mg/mL, 10.0 mg/mL

Oral, Capsule, , Capsule - Oral, Intravenous, Powder, for solution - Intravenous, Powder, for solution, Injection, powder, for solution - Intravenous, Injection, powder, for solution, Injection, powder, lyophilized, for solution, Injection, powder, lyophilized, for solution - Intravenous

Warnings

Temozolomide has one contraindication, and thus should be avoided in cases where the conditions in the following table are present.

Temozolomide Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Temozolomide may interact with Pulse Frequency

There are 20 known major drug interactions with Temozolomide.

Common Temozolomide Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Major

The risk or severity of adverse effects can be increased when Temozolomide is combined with 2-Methoxyethanol.

9-(N-methyl-L-isoleucine)-cyclosporin A

Major

The risk or severity of adverse effects can be increased when Temozolomide is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abatacept

Major

The risk or severity of adverse effects can be increased when Temozolomide is combined with Abatacept.

Abetimus

Major

The risk or severity of adverse effects can be increased when Temozolomide is combined with Abetimus.

Acteoside

Major

The risk or severity of adverse effects can be increased when Temozolomide is combined with Acteoside.

Temozolomide Toxicity & Overdose Risk

Taking high doses of temozolomide can lead to myelosuppression, which is reduced production of blood cells. This can cause infection and death. For example, one patient who took 2000 mg/day for five days suffered from decreased production of all types of blood cells, fever, and failure of multiple organs, which eventually led to death. If someone overdoses on temozolomide, they should be monitored for changes in their blood count and given supportive care if needed.

image of a doctor in a lab doing drug, clinical research

Temozolomide Novel Uses: Which Conditions Have a Clinical Trial Featuring Temozolomide?

217 active trials are being conducted to assess the potential of Temozolomide to treat melanoma, Primary Central Nervous System Lymphoma (PCNSL) and Glioblastoma.

Condition

Clinical Trials

Trial Phases

Anaplastic astrocytoma

0 Actively Recruiting

Mycosis Fungoides

5 Actively Recruiting

Phase 2, Phase 1

Procarbazine treatment

0 Actively Recruiting

melanoma

0 Actively Recruiting

Soft Tissue Sarcoma

51 Actively Recruiting

Phase 2, Not Applicable, Phase 1, Phase 4, Early Phase 1, Phase 3

Advance Directives

0 Actively Recruiting

Glioblastoma

61 Actively Recruiting

Phase 1, Phase 2, Early Phase 1, Not Applicable, Phase 3

Disease Progression

0 Actively Recruiting

Neuroblastoma

0 Actively Recruiting

Sarcoma, Ewing

0 Actively Recruiting

Nitrosourea treatment

0 Actively Recruiting

Primary Central Nervous System Lymphoma (PCNSL)

18 Actively Recruiting

Phase 1, Phase 2

Advance Directives

0 Actively Recruiting

Radiotherapy

7 Actively Recruiting

Phase 1, Not Applicable, Phase 3, Phase 2

Temozolomide Reviews: What are patients saying about Temozolomide?

3.7

Patient Review

6/7/2009

Temozolomide for A Type of Brain Cancer - Anaplastic Astrocytoma

This can help take the edge off of pain.

3.7

Patient Review

11/1/2007

Temozolomide for Malignant Brain Tumor Glioblastoma

image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about temozolomide

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of chemotherapy is temozolomide?

"The drug Temozolomide is an anti-cancer chemotherapy drug that works by classified as an "alkylating agent.""

Answered by AI

How toxic is temozolomide?

"The most common side effects of temozolomide are gastrointestinal problems, such as nausea, vomiting, and appetite loss. Anti-emetics were given to 179 out of 244 patients who experienced nausea and vomiting."

Answered by AI

What is temozolomide used for?

"Temozolomide is a cancer medication used to treat brain cancer in patients whose tumors have returned or been newly diagnosed. It is classified as an antineoplastic medication."

Answered by AI

What are temozolomide side effects?

"Common side effects of this medication include nausea, vomiting, loss of appetite, changes in taste, and constipation. You may also experience tiredness, dizziness, headache, or trouble sleeping. These side effects are usually mild and improve over time. If you experience severe nausea or vomiting, your doctor may prescribe medication to help relieve these symptoms."

Answered by AI

Clinical Trials for Temozolomide

Image of Ohio State University Hospital in Columbus, United States.

Gene Therapy for Brain Cancer

18 - 70
All Sexes
Columbus, OH

The goal of this clinical trial is to first define the Safety and Optimal Biological Dose (OBD) of study drug TGX-007 and to then further investigate the safety and efficacy in patients with newly diagnosed or recurrent Glioblastoma. TGX-007 is a gene therapy drug delivered by a harmless adeno-associated virus (AAV) vector which delivers two combined therapeutic payloads to enable killing of proliferative cells and activation of an anti-tumour immune response. One is herpes simplex virus thymidine kinase (HSV-tk), which converts the pro-drug valaciclovir into an active drug that can kill tumour cells and the other is interleukin 12 (IL-12), which activates the body's immune system to recognise and fight the tumour. Patients newly diagnosed with glioblastoma suitable for standard of care surgery and chemoradiotherapy or patients with recurrent glioblastoma suitable for further surgery may be eligible for the study. Patients will receive TGX-007 by a direct intratumoural injection and will then take the pro-drug valacyclovir orally for up to 21 days before proceeding to standard of care surgery. The study is split into two phases. Phase I will treat patients at different dose levels of TGX-007 to identify the Optimal Biological Dose that will be used to further expand the study into Phase II. Phase II will expand the number of patients treated at the selected OBD to investigate how effective TGX-007 is at treating newly diagnosed and recurrent GBM. Approximately 68 people aged 18-70 will take part in the study.

Phase 1 & 2
Waitlist Available

Ohio State University Hospital

Trogenix ltd

Image of University of Virginia in Charlottesville, United States.

Ultrasound + Immunotherapy for Glioblastoma

18 - 70
All Sexes
Charlottesville, VA

This is a phase 1 study for patients with newly diagnosed MGMT unmethylated IDH wild-type glioblastoma utilizing autologous activated T-cells armed with bispecific antibody (EGFR-BATs) that recognize the tumor. The investigators hypothesized that the combination of infusions of EGFR BATs and low-intensity focused ultrasound would induce blood-brain barrier opening and increase the permeability of the adoptive immunotherapy. The investigators will radiolabel the EGFR BATs with 89Zr-oxine for subsequent PET imaging to determine the trafficking and uptake of this approach. There is a concern that several infusions of EGFR BATs before BBB opening could change the immune tumor microenvironment that would not allow a permissive BBB after LIFU. Therefore, Arm A will have two LIFU with BBB opening after the 4th and the 8th infusion, and Arm B will have three LIFU with BBB opening after the 1st, 4th, and 8th infusions. This study will determine the safety and feasibility of the combination of low-intensity focused ultrasound (LIFU) with microbubbles BBB opening and EGFR BATs and the access of the adoptive cell immunotherapy to the tumor microenvironment to inform future studies.

Phase 1
Recruiting

University of Virginia

Camilo Fadul, M.D.

NaviFUS Corporation

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Virtual vs Telephone Education for Breast Cancer

18+
All Sexes
Toronto, Canada

The goal of this clinical trial is to compare whether the use of videoconferencing in breast cancer patients undergoing radiotherapy is better for pre-treatment education than telephone calls. The main question it aims to answer is in breast cancer patient receiving radiotherapy, does videoconferencing, compared to telephone calls for pre-treatment education result in decreased procedural fears and concerns? The investigators hypothesize that the use of videoconferencing for pre-treatment radiotherapy education will decrease breast cancer patients' procedural fears and concerns. Researchers will compare the current standard of care in a 30 minute radiation therapist led pre-treatment education call to the intervention of a 45 minute radiation therapist led videoconferencing call to see if the intervention reduces patient procedural fears and concerns, anxiety levels, and has higher patient satisfaction. Participants will be asked to complete questionnaires at three time points: 1. Baseline - at time of study consent. 2. CT-Simulation - after their radiotherapy CT-Simulation appointment. 3. Day 1 Treatment - after their first day of radiotherapy treatment.

Waitlist Available
Has No Placebo

Princess Margaret Cancer Center

Image of Mayo Clinic in Phoenix, United States.

MT-125 for Glioblastoma

18+
All Sexes
Phoenix, AZ

The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with your standard of care treatment. Initially, participants with newly diagnosed glioblastoma will be given different doses of MT-125 in combination with radiotherapy (RT) with the goal of identifying the highest tolerated dose. Up to 36 people with glioblastoma who are at least18 years old are being invited to join this study. MT-125 is a type of study treatment which acts on cancer cells in the brain to destroy them. It will be administered on the same day as your standard of care radiotherapy because it is also designed to help radiotherapy work better. However, this is the first time MT-125 will be studied in humans. Therefore, the use is considered investigational. If you would like more details about MT-125 in glioblastoma participants, please ask the Study Doctor. You will be among the first participants with glioblastoma to receive this study treatment. Its safety and effectiveness have not yet been established in humans. Thus, we do not know whether it will work for you. Your condition may improve, may get worse, or there may be no change. The selected participant population-individuals newly diagnosed with histologically and/or molecularly confirmed IDH wild-type, MGMT-unmethylated glioblastoma-represents those least likely to experience safety concerns or adverse events related to the study treatment, and most likely to derive therapeutic benefit. There are certain tests/questions you must complete to find out if you meet the requirements to be in the study. If you do not meet these requirements, you cannot take part in the study. If this happens, you can talk to your Study Doctor about other options.

Phase 1
Waitlist Available

Mayo Clinic (+2 Sites)

Myosin Therapeutics Inc.

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BOLD-100 + Doxorubicin for Cancer

18+
All Sexes
Toronto, Canada

A Phase 1b, non-randomized, single-institution trial designed to assess the safety, tolerability and the highest dose with acceptable toxicity (RP2D) of BOLD-100 in combination with doxorubicin in patients diagnosed with advanced soft tissue sarcomas. The trial is divided into two phases: an initial dose-escalation phase for BOLD-100, followed by a dose-expansion phase based on the recommended dose for Phase 2. In the dose-escalation phase, we plan to enroll 12-15 patients, with an additional 17 patients in the dose-expansion phase. Participants will receive BOLD-100 intravenously on Days 1 and 8 of a 21-day cycle, in combination with doxorubicin (75 mg/m², intravenous) administered on Day 1 of each 21-day cycle for up to six cycles. Participants will continue to receive BOLD-100 for as long as the cancer is not getting worse, The maximum cycles of doxorubicin are 6 cycles. Participants will undergo a screening assessment prior to the start treatment to determine eligibility for enrollment. Treatment will commence on Day 1 and will continue until the protocol-defined criteria for treatment withdrawal are met. Disease response will be assessed using CT or MRI scans, starting at 12 weeks after the initiation of treatment and continuing every 12 weeks until withdrawal. Upon treatment discontinuation or study withdrawal, a post-treatment assessment will be conducted at end of treatment and at 30 days of the last BOLD-100 dose, with follow-up visits scheduled every 3 months thereafter.

Phase 1
Waitlist Available

UHN- Princess Margaret Cancer Center

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