Telehealth vs In-Person Assessments for Brain Tumors

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must be taking: Oral chemotherapy

Disqualifiers: Pregnant, Nursing, Imprisoned, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether glioma patients receiving oral chemotherapy prefer telehealth or in-person assessments. Gliomas, a type of brain tumor, can cause symptoms like tiredness, memory issues, and trouble communicating. The trial involves patients taking the chemotherapy drug temozolomide and experiencing both types of assessments after each treatment cycle. Participants must have a glioma diagnosis and be eligible for temozolomide treatment. The research aims to determine which assessment method offers better satisfaction and convenience for patients. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping to understand how it benefits more patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What is the safety track record for the treatments in this trial?

Research has shown that temozolomide often treats gliomas, a type of brain tumor, and helps extend life when combined with radiation therapy. Studies have found that prolonged use of temozolomide does not increase the risk of blood-related side effects. However, some side effects, such as nausea and tiredness, have been reported. This indicates that temozolomide is generally well-tolerated, though patients might still experience some discomfort. ^{1 2 3 4 5}

Why are researchers enthusiastic about this trial?

Researchers are excited about this trial because it explores how telehealth could change the game for brain tumor assessments. Normally, patients have to travel for in-person visits, which can be tough and time-consuming. This trial is testing whether telehealth assessments, combined with the chemotherapy drug temozolomide, can offer the same level of care with more convenience. If successful, this could mean fewer trips to the hospital, making life a little easier for patients while still keeping a close eye on their health.

What evidence suggests that telehealth assessments are effective for glioma patients?

Research has shown that temozolomide, which participants in this trial will receive, effectively treats brain tumors like glioblastoma. Studies have found that patients taking temozolomide tend to live longer, with one study reporting an average survival time of about 17 months. Another study discovered that using temozolomide with radiation increased the 10-year survival rate to 70%, compared to 47% with radiation alone. While temozolomide works well, it can cause side effects, such as problems with blood cells. Clinical research strongly supports the effectiveness of temozolomide, making it a reliable option for treating these brain tumors. ^{1 4 6 7 8}

Who Is on the Research Team?

Tufia C. Haddad, MD

Principal Investigator

Mayo Clinic

Ugur T Sener, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for glioma patients undergoing oral chemotherapy who may benefit from telehealth assessments. Ideal participants are those with brain tumors like glioblastoma, oligodendroglioma, or astrocytoma and experience high symptom burden.

Inclusion Criteria

Expected survival ≥ 6 months in the opinion of treatment team

Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations

Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only

Exclusion Criteria

I am not pregnant, nursing, imprisoned, or unable to understand my medical care.

I cannot swallow pills or have issues absorbing medication taken by mouth.

I do not have any health conditions that would make it unsafe for me to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive temozolomide orally once daily on days 1-5 of each cycle, with cycles repeating every 28 days for up to 6 cycles. Assessments alternate between telehealth and in-person visits after each cycle.

6 months

Alternating telehealth and in-person visits after each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up occurring 30 days after the study intervention.

4 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Assessment
• Questionnaire Administration
• Telemedicine Visit
• Temozolomide

Trial Overview The study compares patient satisfaction between telehealth (using technology for remote care) and traditional in-person medical assessments among glioma patients on oral chemotherapy.

How Is the Trial Designed?

Group I: Health services research (temozolomide, telehealth, in-person) Experimental Treatment 4 Interventions

Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles while on study in the absence of disease progression or unacceptable toxicity. Patients complete alternating telehealth assessment visits and in-person assessment visits after each cycle of treatment.

Temozolomide is already approved in European Union, United States for the following indications:

Approved in European Union as Temodal for:

• Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment
• Children from the age of three years, adolescents and adults with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy

Approved in United States as Temodar for:

• Newly diagnosed glioblastoma concomitantly with radiotherapy and subsequently as monotherapy treatment
• Newly diagnosed or refractory anaplastic astrocytoma

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Temozolomide (TMZ) demonstrated a 33% overall response rate in patients with newly diagnosed glioblastoma and anaplastic astrocytoma, with a median overall survival of 14.1 months and progression-free survival of 8.35 months, indicating its efficacy as a treatment option.

The treatment was well-tolerated, with no patients discontinuing due to side effects, and it improved patients' performance status, suggesting that TMZ not only extends survival but also enhances quality of life for those with high-grade gliomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgery, radiotherapy and temozolomide in treating high-grade gliomas. Parlato, C., Barbarisi, M., Moraci, M., et al.[2019]

The study confirmed that the generic temozolomide capsules (TOZ039) are bioequivalent to the brand Temodal® capsules, with pharmacokinetic parameters falling within the acceptable range for both 20-mg and 100-mg doses in 29 patients with brain tumors.

The treatment was found to be safe, with no treatment-related severe adverse events or mortality reported, although 82.8% of patients experienced some adverse effects, highlighting the importance of monitoring patient responses during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal®) in glioma patients in China. Hu, C., Lin, Q., Liu, C., et al.[2021]

In a phase II trial involving 46 patients with progressive low-grade glioma, Temozolomide (Temodar) demonstrated a 61% objective response rate, with 24% achieving complete response and 37% achieving partial response.

The treatment showed promising safety, with limited toxicity observed; however, one patient experienced severe complications, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of temozolomide in patients with progressive low-grade glioma. Quinn, JA., Reardon, DA., Friedman, AH., et al.[2022]

A review of 5,127 reports on temozolomide (TMZ) revealed 112 cases of major hematologic adverse events (HAEs), with a significant number of these cases leading to death, highlighting the serious risks associated with this medication.

Aplastic anemia (AA) and leukemia were the most common major HAEs linked to TMZ, indicating a unique toxicity profile compared to other alkylating agents, and suggesting that patients should be informed about these risks, especially since AA can develop after a short duration of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hematologic adverse events associated with temozolomide. Villano, JL., Letarte, N., Yu, JM., et al.[2018]

Temozolomide (TMZ) is the only anticancer drug proven to improve survival in glioblastoma when used with radiotherapy, showing high concentrations in brain tumors and cerebrospinal fluid, which enhances its effectiveness.

Molecular markers like MGMT promoter methylation can predict better responses to TMZ treatment, but side effects such as myelosuppression and nausea are common, necessitating precautions like prophylaxis against Pneumocystis carinii pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Temozolomide: Temodal]. Shinoura, N., Yamada, R., Tabei, Y., et al.[2018]

Temozolomide (TMZ) is an important chemotherapy drug for treating malignant gliomas, with new intravenous formulations approved based on studies showing they are bioequivalent to oral TMZ.

While oral TMZ has established efficacy in newly diagnosed gliomas, the intravenous version's effectiveness is based on data from oral formulations, and there is currently no comparative data on tolerability or patient satisfaction between the two forms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical appraisal of temozolomide formulations in the treatment of primary brain tumors: patient considerations. García, M., Clopés, A., Bruna, J., et al.[2021]

Temozolomide (TMZ) is an effective oral treatment for malignant gliomas, providing significant survival benefits while being generally well tolerated by patients.

While most side effects of TMZ are mild to moderate, there is a risk of severe hematologic adverse events, such as myelodysplastic syndrome and aplastic anemia, which have been documented in the literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temozolomide-related hematologic toxicity. Scaringi, C., De Sanctis, V., Minniti, G., et al.[2018]

Temozolomide (TMZ) is generally safe with mild to moderate side effects, but this case report highlights a rare instance of severe aplastic anemia (AA) in a 68-year-old female patient following treatment for glioblastoma, indicating a potential serious risk associated with the drug.

The patient's AA was managed successfully with supportive care, including platelet transfusions and growth factor treatment, and her blood counts returned to normal within 38 days, emphasizing the importance of monitoring blood parameters during and after TMZ treatment to detect such rare toxicities early.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temozolomide-induced aplastic anaemia: Case report and review of the literature. Gilbar, PJ., Pokharel, K., Mangos, HM.[2022]

Temozolomide is primarily used for treating refractory central nervous system cancers like anaplastic astrocytoma and glioblastoma, but ongoing clinical trials are exploring its efficacy and safety in newly diagnosed gliomas and other types of tumors.

Research is also investigating different dosing schedules and combinations with other treatments, suggesting that temozolomide could be a versatile option in cancer therapy beyond its current approved uses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Future directions for temozolomide therapy. Yung, WK.[2019]

Temozolomide (TMZ) solutions prepared from a newly approved intravenous powder formulation showed over 90% stability after 9 days at room temperature and 13 weeks at 5°C, indicating a long shelf life for the solution.

This stable formulation could allow for oral administration of TMZ, making it easier for patients, especially children, who have difficulty swallowing capsules, and enabling more precise dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stability of temozolomide in solutions aimed for oral treatment prepared from a commercially available powder for infusion. Nygren, H., Eksborg, S.[2021]

In a phase II trial involving 38 patients with recurrent oligodendroglial tumors, temozolomide (TMZ) demonstrated a high response rate, with 52.6% of patients showing a complete or partial response, indicating its efficacy as a first-line chemotherapy.

TMZ was generally well tolerated, with hematologic side effects being the most common, and only one patient discontinuing treatment due to toxicity, suggesting a favorable safety profile for chemotherapy-naive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of first-line chemotherapy with temozolomide in recurrent oligodendroglial tumors: the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971. van den Bent, MJ., Taphoorn, MJ., Brandes, AA., et al.[2022]

Temozolomide is a chemotherapeutic agent that effectively crosses the blood-brain barrier and has shown a good safety profile in treating brain metastases from solid tumors, with clinical activity observed in heavily pretreated patients.

In a randomized phase II trial, temozolomide combined with radiation therapy resulted in a significantly higher objective response rate (96% vs. 67%) compared to radiation alone, particularly benefiting patients with newly diagnosed brain and lung metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temozolomide for treating brain metastases. Abrey, LE., Christodoulou, C.[2019]

Citations

1. withpower.com withpower.com/trial/phase-4-oligodendroglioma-idh-mutant-and-1p19q-codeleted-10-2024-f8d24

Telehealth vs In-Person Assessments for Brain Tumors In a phase II trial involving 38 patients with recurrent oligodendroglial tumors, temozolomide (TMZ) demonstrated a high response rate, with 52.6% of patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11275351/

Temozolomide (TMZ) in the Treatment of Glioblastoma ... TMZ, while effective in treating brain tumors, can cause various side effects. One of the most commonly encountered toxicities is hematological ...

3. pharmacytimes.com pharmacytimes.com/view/study-chemotherapy-to-treat-glioblastoma-may-be-more-effective-during-morning

Study: Chemotherapy to Treat Glioblastoma May Be More ... Patients with glioblastoma receiving temozolomide in the morning had an average overall survival of about 17 months, compared to an average ...

4. ecog-acrin.org ecog-acrin.org/press-release-adding-the-chemotherapy-pill-temozolomide-to-radiation-therapy-improves-survival-in-adult-patients-with-glioma-a-slow-growing-type-of-brain-cancer/

Clinical trial finds that adding the chemotherapy pill ... “We found that the 10-year survival rate was 70% with the combined treatment with temozolomide chemotherapy and radiation, compared to 47% with ...

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13757-1

The role of temozolomide as adjuvant therapy in glioblastoma ... TMZ has been shown to significantly improve patient outcomes, notably increasing the median overall survival compared to RT alone [2]. This ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa043330

Radiotherapy plus Concomitant and Adjuvant ... The addition of temozolomide to radiotherapy for newly diagnosed glioblastoma resulted in a clinically meaningful and statistically significant ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0753332223009654

Strategies increasing the effectiveness of temozolomide at ... Our paper is focused on the most recent developments in the field of nano/biomaterials-based systems for temozolomide delivery and their functionalization.

8. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1437436/full

Comprehensive understanding of the adverse effects ... Temozolomide, which is the standard drug for glioma treatment, has several Adverse events (AEs) in the treatment of gliomas and other tumors that are not yet ...