All > Ewing Sarcoma

Irinotecan for Ewing Sarcoma

Boston Children's Hospital / Dana Farber Cancer Institute, Boston, MA
Ewing SarcomaIrinotecan - Drug
Eligibility
6 - 99
All Sexes

Study Summary

This trial is testing if trabectedin and irinotecan can treat Ewing's sarcoma that has a EWS-FLI1 mutation. Patients will get an infusion of 18F-FLT and have a PET scan to see if the treatment is working.

Eligible Conditions
  • Ewing Sarcoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Similar Trials

1
Single infusion of Temsirolimus
1
Irinotecan
1
IVLP in single lung

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: up to 5 years

up to 36 months
18F-FLT PET Activity
18F-FLT PET avidity of Ewing sarcoma tumors.
6- month Progression free survival
Irinotecan
Tumor response rate
up to 5 years
Duration of Response
Progression free survival

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Single infusion of Temsirolimus
1
Irinotecan
1
IVLP in single lung

Side Effects for

Bevacizumab: Phase A and Phase B
68%Nausea
63%Fatigue
63%Neuropathy peripheral
55%Diarrhoea
40%Constipation
31%Abdominal pain
30%Palmar-plantar erythrodysaesthesia syndrome
28%Vomiting
25%Neutropenia
24%Mucosal inflammation
23%Epistaxis
22%Decreased appetite
20%Insomnia
20%Paraesthesia
20%Gastrooesophageal reflux disease
20%Alopecia
19%Headache
18%Hypertension
17%Back pain
17%Stomatitis
16%Dysgeusia
16%Rash
16%Urinary tract infection
14%Pain in extremity
14%Upper respiratory tract infection
13%Mouth ulceration
13%Thrombocytopenia
13%Arthralgia
12%Dysaesthesia
12%Anaemia
11%Weight decreased
11%Musculoskeletal pain
11%Oedema peripheral
10%Dyspnoea
10%Cough
10%Pulmonary embolism
10%Abdominal pain upper
10%Dizziness
10%Dyspepsia
9%Depression
9%Dysphonia
9%Pyrexia
8%Anxiety
8%Proteinuria
8%Fall
8%Dry skin
7%Rectal haemorrhage
7%Abdominal distension
7%Lethargy
7%Toothache
7%Neck pain
6%Dehydration
6%Non-cardiac chest pain
6%Rhinorrhoea
6%Oropharyngeal pain
5%Muscle spasms
5%Intestinal obstruction
5%Oral herpes
5%Sepsis
5%Nail disorder
5%Hypotension
5%Haemorrhoids
5%Oral candidiasis
5%Hypoalbuminaemia
5%Hypokalaemia
2%Angina pectoris
2%Small intestinal obstruction
2%Flank pain
2%Enterovesical fistula
2%Pneumonia
2%Febrile neutropenia
2%Gastroenteritis
2%Lower respiratory tract infection
2%Anal abscess
2%Bronchitis
2%Renal failure acute
2%Confusional state
1%Thrombophlebitis superficial
1%Anal fissure
1%Visual impairment
1%Colitis
1%Gastritis
1%Ileus
1%Inguinal hernia
1%Intestinal perforation
1%Large intestinal obstruction
1%Large intestine perforation
1%Melaena
1%Neutropenic colitis
1%Catheter site pain
1%Enterocolitis infectious
1%Eyelid infection
1%Infusion related reaction
1%Hypophagia
1%Urinary incontinence
1%Pneumonia aspiration
1%Rectal perforation
1%Dysphagia
1%Colonic obstruction
1%Haematuria
1%Gangrene
1%Urosepsis
1%Pneumonia streptococcal
1%Radius fracture
1%Musculoskeletal chest pain
1%Procedural pain
1%Cerebrovascular accident
1%Extravasation
1%Gastrointestinal perforation
1%Gastrointestinal haemorrhage
1%Cholecystitis acute
1%Infective exacerbation of chronic obstructive airways disease
1%Abscess limb
1%Lobar pneumonia
1%Pilonidal cyst
1%Ear infection
1%Wound infection
1%Procedural site reaction
1%Hemiparesis
1%Clostridium difficile colitis
1%Device related infection
1%Muscle abscess
1%Pleural effusion
1%Pharyngitis
1%Laceration
1%Hypomagnesaemia
1%Infected dermal cyst
1%Gastroenteritis viral
1%Syncope
1%Transient ischaemic attack
1%Acute psychosis
1%Pleuritic pain
1%Hydronephrosis
1%Jugular vein thrombosis
1%Orthostatic hypotension
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT01588990) in the Bevacizumab: Phase A and Phase B ARM group. Side effects include: Nausea with 68%, Fatigue with 63%, Neuropathy peripheral with 63%, Diarrhoea with 55%, Constipation with 40%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Trabectedin and Irinotecan
1 of 1

Experimental Treatment

48 Total Participants · 1 Treatment Group

Primary Treatment: Irinotecan · No Placebo Group · Phase 1 & 2

Trabectedin and IrinotecanExperimental Group · 4 Interventions: Trabectedin 1 MG [Yondelis], Irinotecan, tumor biopsy, 3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging · Intervention Types: Drug, Drug, DiagnosticTest, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
tumor biopsy
2011
Completed Phase 2
~70

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Sarcoma Alliance for Research through CollaborationLead Sponsor
24 Previous Clinical Trials
1,866 Total Patients Enrolled
1 Trials studying Ewing Sarcoma
34 Patients Enrolled for Ewing Sarcoma
Janssen Scientific Affairs, LLCIndustry Sponsor
145 Previous Clinical Trials
578,004 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,283 Previous Clinical Trials
41,235,350 Total Patients Enrolled
8 Trials studying Ewing Sarcoma
2,218 Patients Enrolled for Ewing Sarcoma
National Institutes of Health (NIH)NIH
2,552 Previous Clinical Trials
24,612,544 Total Patients Enrolled
John Glod, MD/PhDStudy DirectorNational Cancer Institute (NCI)
Patrick Grohar, MD/PhDPrincipal InvestigatorChildren's Hospital of Philadelphia

Eligibility Criteria

Age 6 - 99 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your organs need to be working properly.
References

Frequently Asked Questions

Does this research accommodate geriatric participants?

"This clinical trial seeks participants ranging in age from 10 to 99 years old. Additionally, there are 210 studies specifically for minors and 614 studies dedicated towards patients 65 and older." - Anonymous Online Contributor

Unverified Answer

In what common medical scenarios is Irinotecan deployed?

"The main therapy used to treat rna-binding protein fus is Irinotecan. Furthermore, this medication has been successful in treating colorectal carcinoma, ovarian cancer, and sarcoma as well." - Anonymous Online Contributor

Unverified Answer

Could you provide a summary of the research conducted on Irinotecan?

"In 2002, irinotecan was initially explored at Mayo Clinic in Rochester. Subsequently, 556 clinical trials were concluded with the drug and there are still 278 active research projects - many of them based out of Bethesda, Maryland." - Anonymous Online Contributor

Unverified Answer

Is this research experiment currently welcoming participants?

"Yes, according to clinicaltrials.gov this medical trial is presently searching for 45 subjects at 6 sites. It was initially posted on May 1st 2021 and its information has been most recently updated on August 15th 2022." - Anonymous Online Contributor

Unverified Answer

Which demographics are being considered for this clinical experiment?

"This medical trial is open to individuals between the ages of 10 and 99 who have been diagnosed with ewing sarcoma. Approximately 45 participants are being sought for this project." - Anonymous Online Contributor

Unverified Answer

Are there numerous locations where this experimental research is taking place within the city limits?

"Currently, 6 clinical trial sites are accepting participants for this study located in Bethesda, Boston, Los Angeles and several other cities. To best accommodate your needs it is advised that you choose the closest institution to minimize travel costs." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned Irinotecan for usage?

"Irinotecan's safety has only been assessed in minimal capacity, so it was assigned a rating of 1 on our scale from 1 to 3." - Anonymous Online Contributor

Unverified Answer

How many individuals have volunteered to take part in this scientific experiment?

"Yes, according to clinicaltrials.gov the research initiative is presently recruiting participants after being initially posted on May 1st 2021 and last updated on August 15th 2022. 45 study volunteers are needed from 6 different centres." - 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.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top