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Topotecan for Brain Tumor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brain TumorTopotecan - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 48 weeks

Treatment day 1
Distribution of topotecan in tumor tissue
Extent of topotecan backflow
Up to 48 weeks
Number of Adverse Events (AEs) experienced by participants

Trial Safety

Safety Progress

1 of 3

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Side Effects for

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

Trial Design

1 Treatment Group

Cleveland Multiport Catheter (CMC) + Topotecan
1 of 1

Experimental Treatment

5 Total Participants · 1 Treatment Group

Primary Treatment: Topotecan · No Placebo Group · Phase < 1

Cleveland Multiport Catheter (CMC) + Topotecan
Drug
Experimental Group · 1 Intervention: Topotecan · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topotecan
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 weeks

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
503 Previous Clinical Trials
126,011 Total Patients Enrolled
Michael Vogelbaum, M.D, PhDPrincipal InvestigatorMoffitt Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You understand the study requirements and agree to comply with the study requirements by providing written informed consent.
MRI demonstrates a mass that does not require resection to relieve clinically significant mass effect.
References

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