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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase IV trial compares patient satisfaction with telehealth versus in-person neuro-oncology assessments among glioma patients receiving oral chemotherapy. Gliomas are the most common primary central nervous system cancer and are associated with a high symptom burden, such as drowsiness, fatigue, memory difficulty, and difficulty communicating. Care at a high volume center is associated with an overall survival benefit, however, many patients may have physical or financial difficulties preventing access to these centers. Telehealth visits use computers, cameras, videoconferencing, the internet, satellite, and wireless communications to deliver healthcare, while in-person visits require the interaction to take place in the physical presence of someone else. Telehealth neuro-oncology assessments may be preferable compared to in-person assessments in glioma patients receiving oral chemotherapy.

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 data supports the effectiveness of the drug Temozolomide for brain tumors?

Temozolomide has been shown to improve survival in patients with glioblastoma when used with radiotherapy, and it is effective for various brain tumors, including glioma and primary CNS lymphoma. It has demonstrated high response rates in recurrent anaplastic astrocytoma and is considered a useful agent for treating a variety of cancers. ^{1 2 3 4 5}

Is temozolomide safe for humans?

Temozolomide is generally considered safe and well-tolerated, with common side effects like fatigue, nausea, and vomiting. However, it can cause serious blood-related side effects, such as myelodysplastic syndrome (a bone marrow disorder) and aplastic anemia (a condition where the body stops producing enough new blood cells), though these are rare. ^{6 7 8 9 10}

What makes the drug Temozolomide unique for treating brain tumors?

Temozolomide is unique because it can cross the blood-brain barrier, which many other drugs cannot do, making it effective for treating brain tumors. It is available in both oral and intravenous forms, providing flexibility for patients who may have difficulty swallowing pills or need alternative administration methods. ^{1 2 6 11 12}

Research Team

Ugur T Sener, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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]

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]

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 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 (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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Future directions for temozolomide therapy. [2019]

2. India pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Surgery, radiotherapy and temozolomide in treating high-grade gliomas. [2019]

5. Japan pubmed.ncbi.nlm.nih.gov

[Temozolomide: Temodal]. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal®) in glioma patients in China. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Phase II trial of temozolomide in patients with progressive low-grade glioma. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Hematologic adverse events associated with temozolomide. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Temozolomide-related hematologic toxicity. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Critical appraisal of temozolomide formulations in the treatment of primary brain tumors: patient considerations. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Temozolomide for treating brain metastases. [2019]