← Back to Search

Alkylating agents

temozolomide followed by high dose busulfan and thiotepa for Central Nervous System Cancer

Phase 2

Waitlist Available

Led By Thomas Kaley, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new, high-dose chemotherapy regimen to see if it is more effective than the old one, and if it has fewer side effects.

Eligible Conditions

Central Nervous System Cancer
Central Nervous System Brain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progession Free Survival

Secondary outcome measures

Number of Participants Evaluated for Toxicities

Side effects data

From 2023 Phase 2 trial • 60 Patients • NCT00588523

28%

Nausea

27%

Leukocytes

22%

Neutrophils

17%

Vomiting

17%

Febrile neutropenia

17%

Hemoglobin

13%

Platelets

12%

Diarrhea

10%

Fatigue

10%

Seizure

Fever

Rash/desquamation

Lymphopenia

Edema

Headache

Pain - other

Alopecia

Abdominal pain/cramping

Anorexia

AST, SGOT

Constipation

Pneumonia

Muscle weakness - whole body/general

Dehydration

Veno-Occlusive Disease

Abdominal cramping

Infection w/out neutropenia

Confusion

Wound infection

Bilirubin

Thrombosis

Derm, skin other

Fracture

Pancreatitis

White blood cells

Infection unk ANC

Mood alteration/anxiety

Hematoma

Hypertension

Hypotension

Encephalopathy

Rash, dequamation

CNS Hemorrhage

CNS Necrosis/cystic progression

Delusions

Liver dysfunction/failure

Neutrophils/granulocytes (ANC/AGC)

Ascites

Insomnia

Neurology, other

Colitis

Gastrointestinal, other

Catheter related infection

100%

80%

60%

40%

20%

Study treatment Arm

Participants With Newly Diagnosed Anaplastic Oligodendroglioma

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

temozolomide followed by high dose busulfan and thiotepa

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER

2,933 Previous Clinical Trials

13,198,421 Total Patients Enrolled

1 Trials studying Central Nervous System Cancer

20 Patients Enrolled for Central Nervous System Cancer

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,829 Total Patients Enrolled

University of CalgaryOTHER

792 Previous Clinical Trials

869,094 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given their stamp of approval to a treatment regimen featuring temozolomide, high dose busulfan, and thiotepa?

"Despite no evidence of efficacy, temozolomide accompanied by high dose busulfan and thiotepa garnered a score of 2 due to limited safety data."

Answered by AI

Are there any unfilled vacancies available in this research endeavor?

"According to the info on clinicaltrials.gov, no further participants are being recruited for this experiment which was initially posted in September of 2002 and recently updated in October 2022. However, 379 other trials remain open at present time."

Answered by AI

How many participants is the research team enrolling in this experiment?

"This clinical trial is not currently enrolling participants. It went live on September 1st 2002 and was last updated October 3rd 2022, so it might be worth checking back in the future for updates. If you are looking to join a different study, there are 33 trials actively recruiting patients with CNS cancer and 346 studies exploring temozolomide followed by high dose busulfan and thiotepa admitting new individuals at this time."

Answered by AI

Was temozolomide previously incorporated into research protocols that included high dose busulfan and thiotepa?

"Presently, 346 clinical trials are researching the efficacy of temozolomide followed by high dose busulfan and thiotepa with 42 occurring in Phase 3. Philadelphia, Pennsylvania is hosting most of these tests though 6573 medical centres worldwide are contributing to this research."

Answered by AI

What health condition is the combination of temozolomide, busulfan and thiotepa generally utilized to address?

"Temozolomide, in combination with high dose busulfan and thiotepa is frequently prescribed to combat primary central nervous system lymphoma. This same therapy has also been observed to mitigate refractory ewing sarcoma, leukemia, and anaplastic astrocytoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma

2002. "Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00588523.