Temozolomide

Mycosis Fungoides, Advance Directives, Radiotherapy + 11 more
Treatment
20 Active Studies for Temozolomide

What is Temozolomide

TemozolomideThe Generic name of this drug
Treatment SummaryTemozolomide 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.
Temodaris 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 PatientsTemozolomide 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 bodyGlioblastoma 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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, Powder, for solution - Intravenous, Powder, for solution, Intravenous, Injection, powder, for solution, Injection, powder, for solution - Intravenous, 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 RiskTaking 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
60 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?

3.7Patient Review
6/7/2009
Temozolomide for A Type of Brain Cancer - Anaplastic Astrocytoma
This can help take the edge off of pain.
3.7Patient 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 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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Image of UHN- Princess Margaret Cancer Center in Toronto, Canada.

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
Image of City of Hope Medical Center in Duarte, United States.

Glofitamab + Obinutuzumab for Central Nervous System Lymphoma

18+
All Sexes
Duarte, CA
This phase Ib trial tests the safety and side effects of glofitamab after pre-treatment with obinutuzumab and how well they work in treating patients with central nervous system (CNS) lymphoma. Glofitamab is a bispecific antibody that can bind to two different antigens (substances that cause the body to make a specific immune response) at the same time. Glofitamab binds to CD20 on lymphoma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Obinutuzumab can also be administered as a pre-treatment to make glofitamab safer and more tolerable. Giving glofitamab with obinutuzumab pre-treatment may be safe, tolerable, and/or effective in treating patients with CNS lymphoma.
Phase 1
Recruiting
City of Hope Medical CenterJames Godfrey
Have you considered Temozolomide clinical trials? We made a collection of clinical trials featuring Temozolomide, we think they might fit your search criteria.Go to Trials
Image of London Health Sciences Centre in London, Canada.

Temozolomide Timing for Glioblastoma

18+
All Sexes
London, Canada
The body's biological functions follow a circadian rhythm, meaning that individual biological functions in the body change over a 24-hour cycle. There is evidence suggesting that the body and cancer cells may react differently to anti-cancer treatment based on the time of day they are exposed. In fact, researchers have already found that giving anti-cancer treatments at a particular time of the day works better in rectal and ovarian cancer. Temozolomide (TMZ) is a chemotherapy pill/capsule commonly given to patients with newly diagnosed glioblastoma after brain surgery and radiation treatment. However, there is no current standard for what time of day TMZ should be taken for the treatment of glioblastoma. In the current study, participants are randomly placed in one of two groups: a morning group and an evening group. Based on this group placement, participants are instructed to either take their TMZ in the morning or in the evening and record the date and time they take their TMZ in a pill diary. The primary goal of the study is to understand if taking TMZ at a prescribed time of day (morning/evening) is feasible in adults with glioblastoma. This is a pilot trial, and the investigators hypothesize that it will be feasible for glioblastoma patients to take TMZ at the prescribed time of day. The secondary goals of this study are to evaluate participant recruitment, safety, health-related quality of life, and changes in condition over time. This pilot study will help investigators plan for a larger, pragmatic randomized clinical trial in the future.
Recruiting
Has No Placebo
London Health Sciences Centre (+1 Sites)Terry Ng, MD
Image of Brigham and Women's Hospital in Boston, United States.

Intensified Radiation Therapy for Brain Cancer

65+
All Sexes
Boston, MA
Glioblastoma (GBM) is an aggressive malignancy of the central nervous system. Older adults with GBM have a unique constellation of medical, psychosocial, and supportive care needs. To address these challenges, prior work has evaluated the feasibility of hypofractionation, a treatment approach delivering fewer, larger radiation dosages over a shorter time period. Common hypofractionated regimens deliver a lower biologically equivalent radiation dose than the conventional regimens used for younger adults. Whether dose escalated hypofractionation can further improve outcomes in older adults remains unclear. This will be a hybrid randomized control trial comparing the efficacy and safety of dose-escalated and standard hypofractionated radiotherapy among older adults with newly-diagnosed glioblastoma compared to standard three-week course. This research study involves the administration of radiation therapy. Radiation will either be delivered at the standard daily dose or at an increased daily dose over a three weeks course of radiation treatment. Research study procedures will include a screening evaluation to assess eligibility, as well as clinical visits for radiation delivery and to assess symptoms during treatment and at scheduled follow-up times. Participants will be randomly assigned to one of the two arms of the trial: 1. Standard hypofractionated radiation over 3 weeks 2. Dose-escalated hypofractionated radiation over 3 weeks
Phase 2
Recruiting
Brigham and Women's Hospital (+2 Sites)
Image of Arizona Cancer Center at UMC North/University Medical Center in Tucson, United States.

Tarlatamab + Radiation for Cancer

18 - 99
All Sexes
Tucson, AZ
Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites. I) After lead in of 10 patients demonstrating safety of treatment, allow for expansion to cranial sites of disease (N=6-10) with continued enrollment in main cohort II) If toxicity criteria is not met in concurrent RT tarlatamab cohort, we will continue with sequential RT, either A) delivered within 7 days prior to cycle 1 day 1, or B) delivered during cycle 1 -2 but with pre- and post-RT washout of 7 days with no drug during RT, to examine safety in a temporally spaced setting. III) If sequential tarlatamab and radiation is not deemed safe, we would allow for continued enrollment to assess efficacy of drug sans radiation treatment, enriching for tumors not of small cell lung cancer histology and allowing for patients without sites amenable to RT. A nested phase II study will attempt to assess for ORR and safety of study intervention amongst tumors not of small cell lung cancer histology.
Phase 1 & 2
Recruiting
Arizona Cancer Center at UMC North/University Medical CenterCharles Hsu, MDAmgen
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