Telehealth vs In-Person Assessments for Brain Tumors
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Mayo Clinic
Must be taking: Oral chemotherapy
Disqualifiers: Pregnant, Nursing, Imprisoned, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
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.
12345Is 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.
678910What 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.
1261112Eligibility 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
+8 more
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.
Trial 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)
Participant Groups
The study compares patient satisfaction between telehealth (using technology for remote care) and traditional in-person medical assessments among glioma patients on oral chemotherapy.
1Treatment groups
Experimental Treatment
Group I: Health services research (temozolomide, telehealth, in-person)Experimental Treatment4 Interventions
Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles per standard of care 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Future directions for temozolomide therapy. [2019]Although the initial indications of temozolomide (Temodar in the United States, Temodal globally; Schering Corporation, Kenilworth, NJ) therapy are for refractory central nervous system malignancies (anaplastic astrocytoma in the United States and Europe, glioblastoma multiforme in Europe), a number of clinical trials are planned or ongoing to evaluate the efficacy and safety of temozolomide in newly diagnosed glioma, oligodendroglioma, pediatric glioma, brain metastases, metastatic melanoma, and other systemic tumors. Also under investigation are modifications to the temozolomide dosing schedule, other routes of administration, and treatment regimens that include temozolomide in combination with other chemotherapeutic and biologic agents. Temozolomide has the potential to be a useful agent in the treatment of a variety of cancers.
Stability of temozolomide in solutions aimed for oral treatment prepared from a commercially available powder for infusion. [2021]Temozolomide (TMZ) is an alkylating agent with a broad spectrum of antitumor activity, including brain tumors in children. The oral use of TMZ is hampered by the lack of a suitable galenic formulation, since the capsules of TMZ (Temodal™) are large and difficult to swallow. A powder for preparation of a TMZ solution for intravenous administration (2.5 mg/mL) has recently been approved. A possibility to use this formulation for oral administration would facilitate TMZ administration.
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]Oligodendroglial tumors are chemotherapy-sensitive tumors, with two thirds of patients responding to combination chemotherapy with procarbazine, lomustine, and vincristine (PCV). Temozolomide (TMZ), a new alkylating and methylating agent, has demonstrated high response rates in patients with recurrent anaplastic astrocytoma. We investigated TMZ as first-line chemotherapy in recurrent oligodendroglial tumors (OD) and mixed oligoastrocytomas (OA) after surgery and radiation therapy.
Surgery, radiotherapy and temozolomide in treating high-grade gliomas. [2019]Temozolomide (TMZ) a recent, oral, second generation alkylating agent is a chemotherapeutic with demonstrated efficacy for the treatment of high-grade gliomas. The efficacy of TMZ has been demonstrated in both pre-clinical and phase I and II studies. The goal of this study is to determine the activity and safety of temozolomide in improving overall survival (OS), progression-free survival (PFS) and health-related quality of life (HQL) in patient with malignant gliomas treated by surgery, radiotherapy and temozolomide. Twelve patients with newly diagnosed glioblastoma (GBM), and anaplastic astrocytoma (AA) were studied. The mean follow-up period was 12 months. The overall response rate for all histological groups was 33% (4 patients), 6 patients (50%) showed a stabilization of disease. The median progression-free survival (PFS) and overall survival (OS) was respectively 8.35 and 14.1 months; time to progression was 36 week ranging from 20 to 46 In all patients, treatment with temozolomide was associated with improvement of performance status including the patient showing disease progression; Karnofski score improved in all patients by a minimum of 10, with a median of 20 at 6 months. No patient stopped the treatment due to side-effects, no major adverse events were recorded. In two cases of glioblastoma, we observed complete response and after three years, the quality of life is optimal. Surgery allows to establish a histopathological diagnosis, to improve signs and symptoms which are attributable to intracranial hypertension or tumour topography, and to reduce the number of target cells for adjunctive therapies. Radiotherapy improves survival and TMZ chemotherapy that is given after radiotherapy adds survival benefit for patients. Because of its favourable pharmacokinetic and pharmacodynamic properties and improved tolerability. Temozolomide appears to be an ideal, first-line, single-agent, with a safe profile and demonstrated HQL benefits in patients with high-grade gliomas.
[Temozolomide: Temodal]. [2018]The oral alkylating agent, temozolomide (Temodal: TMZ), is the only anticancer drug that has been shown in a phase III study to improve survival in glioblastoma (GBM) when administered with concomitant radiotherapy. Pharmacokinetic studies have documented relatively high concentrations of TMZ in brain tumors and cerebrospinal fluid (20-40% of the area under the plasma concentration curve), and other studies have demonstrated that TMZ is effective for treatment of various brain tumors, including recurrent and newly diagnosed glioma, primary CNS lymphoma, metastatic melanoma, and neuroblastoma. Molecular markers that predict a favorable response to TMZ plus concomitant radiotherapy include methylguanine methyltransferase (MGMT) promoter methylation patients with GBM and chromosome 1p/19q deletion in patients with anaplastic oligodendroglioma or low-grade glioma. Myelosuppression, nausea and constipation are relatively frequent in patients undergoing treatment with TMZ, and prophylaxis against Pneumocystis carinii pneumonia should be instituted. This article will summarize and discuss these issues as well as review ongoing and anticipated studies of TMZ in combination with other anti-cancer therapies.
Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal®) in glioma patients in China. [2021]Label="BACKGROUND">Temozolomide is an alkylating agent approved by the U.S. Food and Drug Administration in 1999 for the treatment of patients with primary brain tumors. The aim of this study was to confirm the bioequivalence and safety of two strengths (20-100 mg) of generic temozolomide in the form of TOZ039 and Temodal® capsules administered to brain tumor patients.
Phase II trial of temozolomide in patients with progressive low-grade glioma. [2022]Temozolomide (Temodar; Schering-Plough Corp, Kenilworth, NJ) is an imidazole tetrazinone that undergoes chemical conversion to the active methylating agent 5-(3-methyltriazen-1yl)imidazole-4-carboximide under physiologic conditions. Previous studies have confirmed activity of Temodar in the treatment of progressive and newly diagnosed malignant gliomas. We have extended these results, and now we report results of a phase II trial of Temodar for patients with progressive, low-grade glioma.
Hematologic adverse events associated with temozolomide. [2018]Temozolomide (TMZ) is a widely used oral alkylating agent that has been associated with the development of severe hematologic adverse events (HAEs). Limited clinical information about HAEs is available.
Temozolomide-related hematologic toxicity. [2018]Temozolomide (TMZ) is an oral alkylating agent used for the treatment of recurrent or newly diagnosed malignant gliomas with significant survival benefit. TMZ is generally well tolerated and safe. The most common side effects are mild to moderate, and are represented by fatigue, nausea, vomiting, thrombocytopenia, and neutropenia. However severe hematologic adverse events (HAEs), including myelodysplastic syndrome and aplastic anemia, have also been reported. In this review we present an overview of the available literature of HAEs after exposure to TMZ.
Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]Temozolomide (TMZ) is an oral alkylating agent principally indicated for neurological malignancies including glioblastoma (GBM) and astrocytoma. Most common side effects are mild to moderate, and include fatigue, nausea, vomiting, thrombocytopenia and neutropenia. Severe or prolonged myelosuppression, causing delayed treatment or discontinuation, is uncommon. Major haematological adverse effects such as myelodysplastic syndrome or aplastic anaemia (AA) have rarely been reported.
Critical appraisal of temozolomide formulations in the treatment of primary brain tumors: patient considerations. [2021]Chemotherapy is assuming an increasingly important role in the treatment of malignant gliomas, of which temozolomide (TMZ) is a key part. TMZ belongs to a class of second-generation imidazotetrazinone prodrugs that exhibit linear pharmacokinetics and do not require hepatic metabolism for activation to the active metabolite. New intravenous (iv) TMZ formulations have recently been approved based on studies of bioequivalence between iv and oral TMZ. The efficacy of TMZ was initially evaluated in patients with recurrent disease but phase II and III trials in newly diagnosed gliomas are available. The results of a large phase III trial that compared RT alone vs RT concomitant with oral TMZ created a new standard of adjuvant treatment. Efficacy data for iv TMZ on which its approval was based are those extrapolated from clinical trials with oral TMZ. No comparative data are available on the differences in tolerability and patient satisfaction between oral and iv formulations of TMZ, or for quality of life. New oral formulations could encourage the adherence of patients to treatment. Although patients presumably would prefer oral treatment, iv formulations may be an alternative in noncompliant patients or patients for whom good adherence could not be expected.
Temozolomide for treating brain metastases. [2019]The metastasis of solid tumors to the brain is associated with a poor prognosis despite aggressive treatment. Available treatment options are limited, as many chemotherapeutic agents do not penetrate the blood-brain barrier. Temozolomide (Temodar in the United States, Temodal globally; Schering Corporation, Kenilworth, NJ) is a novel chemotherapeutic agent with a good safety profile that crosses the blood-brain barrier and has shown activity against many human solid tumors. In two phase II trials of temozolomide in heavily pretreated patients with various solid tumor brain metastases, temozolomide was safe and generally well tolerated and showed clinical activity, with three partial responses and 19 disease stabilizations. Results of a third randomized phase II trial of concurrent administration of temozolomide and radiation therapy followed by adjuvant temozolomide therapy compared with radiation alone showed a higher rate of complete and partial responses (objective response of 96% v 67%) and significantly more complete responses (38% v 33%, P =.017), primarily in patients with newly diagnosed brain and lung metastases.