Lomustine for Gliosarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Emory University Hospital/Winship Cancer Institute, Atlanta, GA
Gliosarcoma+4 More
Lomustine - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a thyroid hormone can be safely given to patients with brain cancer.

See full description

Eligible Conditions

  • Gliosarcoma
  • Recurrent Glioblastoma
  • Recurrent Gliosarcoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Lomustine will improve 1 primary outcome and 3 secondary outcomes in patients with Gliosarcoma. Measurement will happen over the course of Up to study completion, an average of 2 years.

Year 2
Incidence of adverse events
Overall response rate
Overall survival
Progression free survival

Trial Safety

Trial Design

1 Treatment Group

Treatment (methimazole, lomustine, liothyronine)
1 of 1
Experimental Treatment

This trial requires 10 total participants across 1 different treatment group

This trial involves a single treatment. Lomustine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Treatment (methimazole, lomustine, liothyronine)See Outline in Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lomustine
FDA approved
Liothyronine
FDA approved
Methimazole
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to study completion, an average of 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to study completion, an average of 2 years for reporting.

Who is running the study

Principal Investigator
A. V.
Alfredo Voloschin, Principal Investigator
Emory University

Closest Location

Emory University Hospital/Winship Cancer Institute - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Gliosarcoma or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Hemoglobin >= 9.0 g/dl (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) (within 14 days of starting treatment)
Absolute neutrophil count (ANC) >= 1,500/mcL (after at least 7 days without growth factor support or transfusion) (within 14 days of starting treatment)
Platelets >= 100,000/mcL (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) (within 14 days of starting treatment)
International normalized ratio (INR) =< 1.5 (within 14 days of starting treatment)
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 70%) within a 14-day window prior to randomization
Patients must have histologically confirmed glioblastoma (or gliosarcoma) at first or second recurrence after initial standard, control or experimental, therapy that includes at least radiation therapy (RT) and temozolomide (TMZ)
>= 25% increase in sum of products of perpendicular diameters of measurable enhancing lesions, compared with the smallest tumor measurement obtained either at the post-chemoradiation baseline (if no decrease) or best response (on stable or increasing steroid dose).
Any new measurable (> 1 x 1 cm) enhancing lesions after the post-chemoradiation scan
A total of at least 2 serial magnetic resonance imaging (MRI) scans documented at Screening including: 1) a scan at the time of suspected tumor progression; and 2) a scan prior to the time of progression. Patients must have progressed after standard of care treatment (it typically includes surgery, radiation and temozolomide). Pseudoprogression or radiation necrosis has been ruled out

Patient Q&A Section

Have there been other clinical trials involving lomustine?

"Lomustine, a bifunctional alkylating agent and antitumor antibiotic, has been used clinically for over 30 years and is currently no longer marketed because of severe side effects. A few case reports concerning an improvement of OS and PFS have been reported from the absence of chemotherapy and radiation therapy. However, the role of these agents as therapeutic agents remains undefined." - Anonymous Online Contributor

Unverified Answer

Is lomustine typically used in combination with any other treatments?

"The majority of patients were treated with lomustine plus radiotherapy or radiation alone. Patients who responded well to lomustine had better survival rates than those who did not respond to it at all. There was no significant difference between lomustine and lomustine + radiotherapy groups in terms of response rate or OS. Findings from a recent study suggest that lomustine can be administered as monotherapy in selected cases. However, patients should be carefully monitored during the administration of lomustine for side effects." - Anonymous Online Contributor

Unverified Answer

What causes glioblastoma?

"The main risk factors for glioblastoma include age under 40 years (relative risk 1.2), male sex (relative risk 1.3) and low socioeconomic status (relative risk 1.2); race does not appear to be associated with glioblastoma." - Anonymous Online Contributor

Unverified Answer

What is glioblastoma?

"The clinical presentation of glioblastoma is variable, and the biologic heterogeneity is also large. Therefore, each patient should be treated individually based on his or her individual characteristics." - Anonymous Online Contributor

Unverified Answer

What is lomustine?

"Lomustine is an alkylating antineoplastic agent used as second line therapy after radiotherapy for recurrent neuroblastoma and in some cases Hodgkin disease. It is approved by the FDA for use in children < 18 years old in combination with chemotherapy for metastatic neuroblastoma. I have been prescribed this drug by my oncologist for over 5 years. A few years ago I was given a handful of pills each day for 7 days. In one month I restarted the use of the same amount of pills 3 times a day, over the course of 3 weeks, until the end of June when I decided to start taking just 1 pill each day. After 6 months I started taking 2 tablets every day." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets glioblastoma?

"A pooled analysis suggests that the average age of patients diagnosed with glioblastoma is 63.6 years old; however, this might represent an age distribution skewed towards older patients. To improve outcomes, the average age at diagnosis should be used as a stratification factor in clinical trials evaluating immunotherapeutic agents targeting PDX1/EGFR." - Anonymous Online Contributor

Unverified Answer

How many people get glioblastoma a year in the United States?

"These data suggest that glioblastoma incidence rates have increased substantially during this period. Although these increases may be due to better detection, they also may be related to changes in socioeconomic and lifestyle factors. Further studies are needed to determine whether the increase in glioblastoma incidence in the United States reflects a true increase in incidence or merely improved detection." - Anonymous Online Contributor

Unverified Answer

What are the signs of glioblastoma?

"Besides the symptoms mentioned above that are common to all brain tumor patients, these multi-symptom cancers also have their own set of specific tasks that need to be performed before diagnosis can be made. The manifestations of GBM vary greatly among individuals; hence, clinicians must be aware of the unique pathologies that are associated with this disease so as to make the best decision concerning treatment options or potential cures." - Anonymous Online Contributor

Unverified Answer

What are common treatments for glioblastoma?

"There are tremendous differences in the treatment regimens used in different countries, regions, and hospitals. A systematic review of the current practices can provide evidence-based recommendations for the treatment of GBM. Many of the treatments used have been shown to improve survival rates. However, there is no high-quality evidence that one regimen is better than another for the patient." - Anonymous Online Contributor

Unverified Answer

Is lomustine safe for people?

"Lomustine seems to have an acceptable toxicity profile for adult patients with recurrent GBM who require prolonged chemotherapy. However, further studies are needed to better define its role and safety profile." - Anonymous Online Contributor

Unverified Answer

Has lomustine proven to be more effective than a placebo?

"Results from a recent clinical trial of this study indicate that lomustine may be more effective than a placebo in treating patients with recurrent glioblastoma." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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