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Topoisomerase I inhibitor

Topotecan for Brain Tumor

Phase < 1
Waitlist Available
Led By Michael Vogelbaum, M.D, PhD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 weeks
Awards & highlights

Study Summary

This trial is testing an alternative method of delivering Topotecan directly into brain tumors to see if it is safe and well tolerated.

Eligible Conditions
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Distribution of topotecan in tumor tissue
Secondary outcome measures
Extent of topotecan backflow
Number of Adverse Events (AEs) experienced by participants

Side effects data

From 2020 Phase 3 trial • 444 Patients • NCT03061812
58%
ANAEMIA
39%
NEUTROPENIA
35%
THROMBOCYTOPENIA
31%
NAUSEA
27%
FATIGUE
27%
DECREASED APPETITE
22%
CONSTIPATION
19%
DYSPNOEA
19%
LEUKOPENIA
19%
DIARRHOEA
16%
ALOPECIA
16%
ASTHENIA
13%
VOMITING
13%
MALIGNANT NEOPLASM PROGRESSION
12%
COUGH
11%
EPISTAXIS
10%
HYPOKALAEMIA
9%
BACK PAIN
9%
NEUTROPHIL COUNT DECREASED
9%
OEDEMA PERIPHERAL
9%
FEBRILE NEUTROPENIA
9%
ABDOMINAL PAIN
9%
HEADACHE
8%
ARTHRALGIA
7%
INSOMNIA
6%
URINARY TRACT INFECTION
5%
PLATELET COUNT DECREASED
5%
DYSGEUSIA
5%
WEIGHT DECREASED
5%
PARAESTHESIA
5%
PYREXIA
5%
MYALGIA
5%
PNEUMONIA
5%
GENERAL PHYSICAL HEALTH DETERIORATION
4%
PLEURAL EFFUSION
3%
HYPOTENSION
3%
CHEST PAIN
2%
INFLUENZA
2%
HYPOXIA
2%
HYPOALBUMINAEMIA
2%
ASPARTATE AMINOTRANSFERASE INCREASED
2%
PANCYTOPENIA
2%
HYPONATRAEMIA
2%
CONFUSIONAL STATE
2%
SEPSIS
2%
NEOPLASM PROGRESSION
2%
PERICARDIAL EFFUSION
1%
RASH
1%
ORCHITIS
1%
NEUTROPENIC SEPSIS
1%
TUMOUR PAIN
1%
HEPATIC FAILURE
1%
CANDIDA INFECTION
1%
MUSCULAR WEAKNESS
1%
SMALL CELL LUNG CANCER
1%
HAEMATOTOXICITY
1%
CERVICAL CORD COMPRESSION
1%
VERTIGO
1%
RENAL FAILURE
1%
LUNG NEOPLASM MALIGNANT
1%
PNEUMOTHORAX
1%
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
1%
BRONCHITIS
1%
LUNG ABSCESS
1%
ALANINE AMINOTRANSFERASE INCREASED
1%
GASTROENTERITIS
1%
CHOLANGITIS
1%
HYPERGLYCAEMIA
1%
ACUTE MYOCARDIAL INFARCTION
1%
CANCER PAIN
1%
MEMORY IMPAIRMENT
1%
NERVOUS SYSTEM DISORDER
1%
SYNCOPE
1%
ANGINA UNSTABLE
1%
LUNG NEOPLASM
1%
APLASIA
1%
GASTROINTESTINAL HAEMORRHAGE
1%
STAPHYLOCOCCAL INFECTION
1%
FALL
1%
GENERAL PHYSICAL CONDITION ABNORMAL
1%
BONE PAIN
1%
MALIGNANT NEOPLASM OF SPINAL CORD
1%
INTRACRANIAL PRESSURE INCREASED
1%
MENTAL STATUS CHANGES
1%
PNEUMONIA ASPIRATION
1%
RESPIRATORY FAILURE
1%
SUPERIOR VENA CAVA SYNDROME
1%
DISEASE PROGRESSION
1%
EMBOLIC STROKE
1%
NON-CARDIAC CHEST PAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Topotecan
Rovalpituzumab Tesirine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cleveland Multiport Catheter (CMC) + TopotecanExperimental Treatment1 Intervention
For predominantly enhanced tumors with volume of 8 cc or less, only 1 Cleveland Multiport Catheter (CMC) will be placed and convection-enhanced delivery (CED) will be performed over a 4-hour period within an MRI scanner, with the goal of complete tumor coverage (as evidenced by tracer distribution on MRI). The initial rate will be 1.20 ml/hour (5.0 microliters/minute/microcatheter) and infusion will be monitored by intermittent MRI imaging. The rate may be adjusted upwards during the infusion, in the event of incomplete tumor coverage, or downwards, if new mass effect is apparent. Following completion of the 4-hour infusion, the CMC will be removed. The initial rate for each subsequent patient may be adjusted upwards in increments of up to 5 microliters/minute/microcatheter based upon the tumor coverage and safety characteristics of the previously treated patients.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topotecan
2017
Completed Phase 3
~2400

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,988 Total Patients Enrolled
Michael Vogelbaum, M.D, PhDPrincipal InvestigatorMoffitt Cancer Center

Frequently Asked Questions

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

Could you please provide a synopsis of prior experiments involving Topotecan?

"Currently, 61 ongoing Topotecan clinical trials are underway with 17 in the third and final phase. A majority of these studies occur in Saint Louis, Missouri but an impressive 3195 centres across America have active research for this medication."

Answered by AI

What conditions is Topotecan typically prescribed to treat?

"Topotecan is a common treatment for ovarian cancer and can also alleviate the symptoms of acute myelocytic leukemia, sarcoma, and other malignant neoplasms."

Answered by AI

How many subjects is this research project recruiting?

"Affirmative. As indicated by clinicaltrials.gov information, this medical trial is currently recruiting participants and has been since June 20th 2019. The study requires approximately 5 patients who can be found at one single site."

Answered by AI

Is recruitment currently open for this trial?

"Data hosted on clinicaltrials.gov reveals that recruitment for this medical trial is still ongoing; the initial posting was made on June 20th 2019 and has been recently updated as of August 10th 2022."

Answered by AI
~1 spots leftby Mar 2025