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Systemic Anti-Cancer Therapy Regimen Library

Home > SAR Rhabdomyosarcoma Relapsed - VIT [vinCRISTine, irinotecan and temozolomide]

SAR Rhabdomyosarcoma Relapsed - VIT [vinCRISTine, irinotecan and temozolomide]

Treatment Overview

Continue until progression or unacceptable toxicity for up to 12 cycles.

After 12 cycles, consider continuing for individual patients without disease progression.


This regimen contains a medicine where one or more biosimilars may exist. Any biosimilars used have been reviewed by the regulator (Medsafe) and relevant specialists were consulted nationally. Where regulators, in consultation with relevant specialists, have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably.

Cycle 1 - 21 days - temozolomide 125 mg/m2

Cycle length:
21

Cycles 2 to 12 - 21 days - temozolomide 150 mg/m2 (consider if no grade 3 or greater toxicity from Cycle 1)

Cycle length:
21

temozolomide: Dose may be escalated to 150 mg/m2 orally ONCE daily on days 1 to 5 at cycle 2, for patients without grade 3 or greater toxicity from cycle 1.

Cycle details

Cycle 1 - 21 days - temozolomide 125 mg/m2

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1 to 7
ondansetron 8 mg oral administration 1 to 5
temozolomide * 125 mg/m² Once daily oral administration 1 to 5
vinCRISTine * 1.5 mg/m² Cap dose per administration at: 2 mg intravenous 1, 8 10 minutes
irinotecan * 50 mg/m² Once daily intravenous 1 to 5 60 minutes
atropine sulfate * 600 microgram intravenous 1 to 5 2 minutes
ondansetron 8 mg oral administration 1 to 5
pegFILGRASTIM 6 mg subcutaneous injection 6
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

Cycles 2 to 12 - 21 days - temozolomide 150 mg/m2 (consider if no grade 3 or greater toxicity from Cycle 1)

Medication Dose Route Days Max Duration
dexamethasone * 8 mg oral administration 1 to 7
ondansetron 8 mg oral administration 1 to 5
temozolomide * 150 mg/m² Once daily oral administration 1 to 5
vinCRISTine * 1.5 mg/m² Cap dose per administration at: 2 mg intravenous 1, 8 10 minutes
irinotecan * 50 mg/m² Once daily intravenous 1 to 5 60 minutes
atropine sulfate * 600 microgram intravenous 1 to 5 2 minutes
ondansetron 8 mg oral administration 1 to 5
pegFILGRASTIM 6 mg subcutaneous injection 6
domperidone 10 mg Three times daily oral administration 1
loperamide 2 mg oral administration 1

temozolomide: Dose may be escalated to 150 mg/m2 orally ONCE daily on days 1 to 5 at cycle 2, for patients without grade 3 or greater toxicity from cycle 1.

Full details

Cycle 1 - 21 days - temozolomide 125 mg/m2

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy with food.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
temozolomide * 125 mg/m² Once daily oral administration
Instructions:

Take approximately ONE hour prior to vinCRISTine and irinotecan, on an empty stomach - one hour before OR two hours after food.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
vinCRISTine * 1.5 mg/m² Cap dose per administration at: 2 mg intravenous 10 minutes
Instructions:
  • Diluted in a minibag.
  • FOR INTRAVENOUS USE ONLY – fatal if given by any other routes.
  • Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.
irinotecan * 50 mg/m² Once daily intravenous 60 minutes
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:

Only if required for acute diarrhoea or cholinergic symptoms.

  • Alternatively, dose may be administered subcutaneously.
  • 600 microgram = 0.6 mg.
  • Some centres may wish to give a reduced dose of 300 microgram (= 0.3 mg) in line with institutional policy.
  • Dose may be repeated up to a maximum dose of 1200 microgram (= 1.2 mg).
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.
domperidone 10 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
temozolomide * 125 mg/m² Once daily oral administration
Instructions:

Take approximately ONE hour prior to irinotecan, on an empty stomach - one hour before OR two hours after food.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
irinotecan * 50 mg/m² Once daily intravenous 60 minutes
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:

Only if required for acute diarrhoea or cholinergic symptoms.

  • Alternatively, dose may be administered subcutaneously.
  • 600 microgram = 0.6 mg.
  • Some centres may wish to give a reduced dose of 300 microgram (= 0.3 mg) in line with institutional policy.
  • Dose may be repeated up to a maximum dose of 1200 microgram (= 1.2 mg).
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
temozolomide * 125 mg/m² Once daily oral administration
Instructions:

Take approximately ONE hour prior to irinotecan, on an empty stomach - one hour before OR two hours after food.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
irinotecan * 50 mg/m² Once daily intravenous 60 minutes
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:

Only if required for acute diarrhoea or cholinergic symptoms.

  • Alternatively, dose may be administered subcutaneously.
  • 600 microgram = 0.6 mg.
  • Some centres may wish to give a reduced dose of 300 microgram (= 0.3 mg) in line with institutional policy.
  • Dose may be repeated up to a maximum dose of 1200 microgram (= 1.2 mg).
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 4

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
temozolomide * 125 mg/m² Once daily oral administration
Instructions:

Take approximately ONE hour prior to irinotecan, on an empty stomach - one hour before OR two hours after food.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
irinotecan * 50 mg/m² Once daily intravenous 60 minutes
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:

Only if required for acute diarrhoea or cholinergic symptoms.

  • Alternatively, dose may be administered subcutaneously.
  • 600 microgram = 0.6 mg.
  • Some centres may wish to give a reduced dose of 300 microgram (= 0.3 mg) in line with institutional policy.
  • Dose may be repeated up to a maximum dose of 1200 microgram (= 1.2 mg).
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 5

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
temozolomide * 125 mg/m² Once daily oral administration
Instructions:

Take approximately ONE hour prior to irinotecan, on an empty stomach - one hour before OR two hours after food.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
irinotecan * 50 mg/m² Once daily intravenous 60 minutes
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:

Only if required for acute diarrhoea or cholinergic symptoms.

  • Alternatively, dose may be administered subcutaneously.
  • 600 microgram = 0.6 mg.
  • Some centres may wish to give a reduced dose of 300 microgram (= 0.3 mg) in line with institutional policy.
  • Dose may be repeated up to a maximum dose of 1200 microgram (= 1.2 mg).
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 6

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.
pegFILGRASTIM 6 mg subcutaneous injection

Day: 7

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.

Day: 8

Medication Dose Route Max duration Details
vinCRISTine * 1.5 mg/m² Cap dose per administration at: 2 mg intravenous 10 minutes
Instructions:
  • Diluted in a minibag.
  • FOR INTRAVENOUS USE ONLY – fatal if given by any other routes.
  • Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.

Cycles 2 to 12 - 21 days - temozolomide 150 mg/m2 (consider if no grade 3 or greater toxicity from Cycle 1)

Day: 1

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy with food.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
temozolomide * 150 mg/m² Once daily oral administration
Instructions:

Take approximately ONE hour prior to vinCRISTine and irinotecan, on an empty stomach - one hour before OR two hours after food.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
vinCRISTine * 1.5 mg/m² Cap dose per administration at: 2 mg intravenous 10 minutes
Instructions:
  • Diluted in a minibag.
  • FOR INTRAVENOUS USE ONLY – fatal if given by any other routes.
  • Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.
irinotecan * 50 mg/m² Once daily intravenous 60 minutes
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:

Only if required for acute diarrhoea or cholinergic symptoms.

  • Alternatively, dose may be administered subcutaneously.
  • 600 microgram = 0.6 mg.
  • Some centres may wish to give a reduced dose of 300 microgram (= 0.3 mg) in line with institutional policy.
  • Dose may be repeated up to a maximum dose of 1200 microgram (= 1.2 mg).
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.
domperidone 10 mg Three times daily oral administration
Instructions:

When required for nausea and/or vomiting.

The choice of rescue antiemetic may be substituted to reflect institutional policy or individual patient characteristics.
loperamide 2 mg oral administration
Instructions:
Take TWO capsules (=4 mg) at onset of loose bowel motions and a further ONE capsule (=2 mg) for every loose bowel motion (maximum of EIGHT capsules in 24 hours), or use as directed by oncologist or haematologist.

Day: 2

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
temozolomide * 150 mg/m² Once daily oral administration
Instructions:

Take approximately ONE hour prior to irinotecan, on an empty stomach - one hour before OR two hours after food.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
irinotecan * 50 mg/m² Once daily intravenous 60 minutes
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:

Only if required for acute diarrhoea or cholinergic symptoms.

  • Alternatively, dose may be administered subcutaneously.
  • 600 microgram = 0.6 mg.
  • Some centres may wish to give a reduced dose of 300 microgram (= 0.3 mg) in line with institutional policy.
  • Dose may be repeated up to a maximum dose of 1200 microgram (= 1.2 mg).
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 3

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
temozolomide * 150 mg/m² Once daily oral administration
Instructions:

Take approximately ONE hour prior to irinotecan, on an empty stomach - one hour before OR two hours after food.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
irinotecan * 50 mg/m² Once daily intravenous 60 minutes
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:

Only if required for acute diarrhoea or cholinergic symptoms.

  • Alternatively, dose may be administered subcutaneously.
  • 600 microgram = 0.6 mg.
  • Some centres may wish to give a reduced dose of 300 microgram (= 0.3 mg) in line with institutional policy.
  • Dose may be repeated up to a maximum dose of 1200 microgram (= 1.2 mg).
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 4

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
temozolomide * 150 mg/m² Once daily oral administration
Instructions:

Take approximately ONE hour prior to irinotecan, on an empty stomach - one hour before OR two hours after food.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
irinotecan * 50 mg/m² Once daily intravenous 60 minutes
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:

Only if required for acute diarrhoea or cholinergic symptoms.

  • Alternatively, dose may be administered subcutaneously.
  • 600 microgram = 0.6 mg.
  • Some centres may wish to give a reduced dose of 300 microgram (= 0.3 mg) in line with institutional policy.
  • Dose may be repeated up to a maximum dose of 1200 microgram (= 1.2 mg).
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 5

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.
ondansetron 8 mg oral administration
Instructions:

ONE hour prior to chemotherapy.
temozolomide * 150 mg/m² Once daily oral administration
Instructions:

Take approximately ONE hour prior to irinotecan, on an empty stomach - one hour before OR two hours after food.

This medicine may make you sleepy and make it dangerous to drive or operate machinery. Limit alcohol intake.
irinotecan * 50 mg/m² Once daily intravenous 60 minutes
atropine sulfate * 600 microgram intravenous 2 minutes
Instructions:

Only if required for acute diarrhoea or cholinergic symptoms.

  • Alternatively, dose may be administered subcutaneously.
  • 600 microgram = 0.6 mg.
  • Some centres may wish to give a reduced dose of 300 microgram (= 0.3 mg) in line with institutional policy.
  • Dose may be repeated up to a maximum dose of 1200 microgram (= 1.2 mg).
ondansetron 8 mg oral administration
Instructions:

EIGHT hours after chemotherapy OR before bed.

Day: 6

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.
pegFILGRASTIM 6 mg subcutaneous injection

Day: 7

Medication Dose Route Max duration Details
dexamethasone * 8 mg oral administration
Instructions:

ONCE daily in the morning with food.

Dose and duration may be individualised at clinician’s discretion.

Day: 8

Medication Dose Route Max duration Details
vinCRISTine * 1.5 mg/m² Cap dose per administration at: 2 mg intravenous 10 minutes
Instructions:
  • Diluted in a minibag.
  • FOR INTRAVENOUS USE ONLY – fatal if given by any other routes.
  • Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.

Supportive Care Factors

Factor Value
Diarrhoea risk: Anti-diarrhoeals are usually prescribed with this treatment
Emetogenicity: Variable
Growth factor support: Recommended for primary prophylaxis
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis may be considered

Emetogenicity: MEDIUM days 1 to 5; MINIMAL day 8.

References

Defachelles AS, Bogart E, Casanova M, Merks JHM, Bisogno G, Calareso G, Gallego Melcon S, Gatz SA, Le Deley MC, McHugh K, Probst A, Rocourt N, van Rijn RR, Wheatley K, Minard-Colin V, Chisholm JC. Randomized Phase II Trial of Vincristine-Irinotecan With or Without Temozolomide, in Children and Adults With Relapsed or Refractory Rhabdomyosarcoma: A European Paediatric Soft Tissue Sarcoma Study Group and Innovative Therapies for Children With Cancer Trial. J Clin Oncol. 2021 Sep 20;39(27):2979-2990. doi: 10.1200/JCO.21.00124. Epub 2021 Aug 3., PMID: 34343032

Centre Oscar LAMBRET. International randomized phase II trial of the combination of vincristine and irinotecan with or without temozolomide (vi or vit) in children and adults with refractory or relapsed rhabdomyosarcoma. Protocol version 5.1 June 24th 2019 https://ascopubs.org/doi/suppl/10.1200/JCO.21.00124/suppl_file/protocol_JCO.21.00124.pdf (accessed 3 March 2023).

Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142., PMID: 28848668

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14., PMID: 29443651

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.