Hypofractionated Radiotherapy for Recurrent DIPG

Recurrent Diffuse Intrinsic Pontine Glioma Clinical Trial

Official title:

Feasibility Study of Hypofractionated Radiotherapy in the Setting of Recurrent Diffuse Intrinsic Pontine Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841435
• Other study ID #: 2017-2183
• Status: Completed
• Phase: N/A
• Start date: January 31, 2018
• Est. completion date: March 3, 2023

Study information

• Verified date: September 2023
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the feasibility of hypofractionated radiotherapy (RT) in the palliative treatment of recurrent diffuse intrinsic pontine glioma (DIPG). Participants will receive 15 Gy in 3 fractions as opposed to the standard 20 Gy in 10 fractions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Years

Eligibility

Inclusion Criteria:

1. Patients must be =30 years of age

2. Patients must have a diagnosis of progressive DIPG.

3. Received prior IMRT based definitive radiotherapy to a dose of =54 Gy.

4. The patient and or parent/legal guardian must be physically and mentally capable of signing the consent form of their own volition.

5. Steroids dosage must be unchanged for 5 days.

6. No Bevacizumab within 21 days (Half-life 11 days ~)

Exclusion Criteria:

1. Patients with incomplete medical records

2. Patients with prior history of reirradiation for DIPG

3. Life expectancy < or equal to 1 month

4. Pregnant women

5. Age >30

6. Prisoners

7. Concurrent systemic therapy at the time of reirradiation

8. Physically or mentally incapable of signing the consent form of their own volition

9. < 6 mos time interval between completion of initial RT to start of reRT.

Related Conditions & MeSH terms

• Diffuse Intrinsic Pontine Glioma
• Glioma
• Recurrence
• Recurrent Diffuse Intrinsic Pontine Glioma

Intervention

Radiation:
• Hypofractionated Radiotherapy
Radiotherapy Treatment, totaling 15 Gy, will be given in 3 fractions over 2 weeks.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (17)

Bouffet E, Hawkins CE, Ballourah W, Taylor MD, Bartels UK, Schoenhoff N, Tsangaris E, Huang A, Kulkarni A, Mabbot DJ, Laperriere N, Tabori U. Survival benefit for pediatric patients with recurrent ependymoma treated with reirradiation. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):1541-8. doi: 10.1016/j.ijrobp.2011.10.039. Epub 2012 Jan 13. — View Citation

Fangusaro J. Pediatric high-grade gliomas and diffuse intrinsic pontine gliomas. J Child Neurol. 2009 Nov;24(11):1409-17. doi: 10.1177/0883073809338960. Epub 2009 Jul 28. — View Citation

Fontanilla HP, Pinnix CC, Ketonen LM, Woo SY, Vats TS, Rytting ME, Wolff JE, Mahajan A. Palliative reirradiation for progressive diffuse intrinsic pontine glioma. Am J Clin Oncol. 2012 Feb;35(1):51-7. doi: 10.1097/COC.0b013e318201a2b7. — View Citation

Freeman CR, Krischer JP, Sanford RA, Cohen ME, Burger PC, del Carpio R, Halperin EC, Munoz L, Friedman HS, Kun LE. Final results of a study of escalating doses of hyperfractionated radiotherapy in brain stem tumors in children: a Pediatric Oncology Group study. Int J Radiat Oncol Biol Phys. 1993 Sep 30;27(2):197-206. doi: 10.1016/0360-3016(93)90228-n. — View Citation

Freese C, Takiar V, Fouladi M, DeWire M, Breneman J, Pater L. Radiation and subsequent reirradiation outcomes in the treatment of diffuse intrinsic pontine glioma and a systematic review of the reirradiation literature. Pract Radiat Oncol. 2017 Mar-Apr;7(2):86-92. doi: 10.1016/j.prro.2016.11.005. Epub 2016 Nov 23. — View Citation

Hoffman LM, Plimpton SR, Foreman NK, Stence NV, Hankinson TC, Handler MH, Hemenway MS, Vibhakar R, Liu AK. Fractionated stereotactic radiosurgery for recurrent ependymoma in children. J Neurooncol. 2014 Jan;116(1):107-11. doi: 10.1007/s11060-013-1259-3. — View Citation

Iqbal MS, Lewis J. An overview of the management of adult ependymomas with emphasis on relapsed disease. Clin Oncol (R Coll Radiol). 2013 Dec;25(12):726-33. doi: 10.1016/j.clon.2013.07.009. Epub 2013 Aug 20. — View Citation

Lassaletta A, Bartels U, Strother D, et al. Hg-57re-irradiation in patients with diffuse intrinsic pontine gliomas, an update on the canadian experience. Neuro-Oncology 2016;18:iii60-iii61.

Liu AK, Foreman NK, Gaspar LE, Trinidad E, Handler MH. Maximally safe resection followed by hypofractionated re-irradiation for locally recurrent ependymoma in children. Pediatr Blood Cancer. 2009 Jul;52(7):804-7. doi: 10.1002/pbc.21982. — View Citation

Massimino M, Biassoni V, Miceli R, Schiavello E, Warmuth-Metz M, Modena P, Casanova M, Pecori E, Giangaspero F, Antonelli M, Buttarelli FR, Potepan P, Pollo B, Nunziata R, Spreafico F, Podda M, Anichini A, Clerici CA, Sardi I, De Cecco L, Bode U, Bach F, Gandola L. Results of nimotuzumab and vinorelbine, radiation and re-irradiation for diffuse pontine glioma in childhood. J Neurooncol. 2014 Jun;118(2):305-312. doi: 10.1007/s11060-014-1428-z. Epub 2014 Apr 3. Erratum In: J Neurooncol. 2018 May 16;: — View Citation

Mayer R, Sminia P. Reirradiation tolerance of the human brain. Int J Radiat Oncol Biol Phys. 2008 Apr 1;70(5):1350-60. doi: 10.1016/j.ijrobp.2007.08.015. Epub 2007 Nov 26. — View Citation

Mayo C, Yorke E, Merchant TE. Radiation associated brainstem injury. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S36-41. doi: 10.1016/j.ijrobp.2009.08.078. — View Citation

Merchant TE, Boop FA, Kun LE, Sanford RA. A retrospective study of surgery and reirradiation for recurrent ependymoma. Int J Radiat Oncol Biol Phys. 2008 May 1;71(1):87-97. doi: 10.1016/j.ijrobp.2007.09.037. — View Citation

Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen Y, Wolinsky Y, Stroup NE, Kruchko C, Barnholtz-Sloan JS. CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2006-2010. Neuro Oncol. 2013 Nov;15 Suppl 2(Suppl 2):ii1-56. doi: 10.1093/neuonc/not151. No abstract available. Erratum In: Neuro Oncol. 2014 May;16(5):760. — View Citation

Packer RJ, Boyett JM, Zimmerman RA, Albright AL, Kaplan AM, Rorke LB, Selch MT, Cherlow JM, Finlay JL, Wara WM. Outcome of children with brain stem gliomas after treatment with 7800 cGy of hyperfractionated radiotherapy. A Childrens Cancer Group Phase I/II Trial. Cancer. 1994 Sep 15;74(6):1827-34. doi: 10.1002/1097-0142(19940915)74:63.0.co;2-q. — View Citation

Packer RJ, Boyett JM, Zimmerman RA, Rorke LB, Kaplan AM, Albright AL, Selch MT, Finlay JL, Hammond GD, Wara WM. Hyperfractionated radiation therapy (72 Gy) for children with brain stem gliomas. A Childrens Cancer Group Phase I/II Trial. Cancer. 1993 Aug 15;72(4):1414-21. doi: 10.1002/1097-0142(19930815)72:43.0.co;2-c. — View Citation

Vanan MI, Eisenstat DD. DIPG in Children - What Can We Learn from the Past? Front Oncol. 2015 Oct 21;5:237. doi: 10.3389/fonc.2015.00237. eCollection 2015. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Radiation Toxicity	RTOG common toxicity criteria grade 0-5	Through Study Completion, an average of 1 year
Secondary	Change in Quality of Life score	Patient reported quality of life via Pediatric Quality of Life Inventory Version 4.0	Pre-RT, 2 weeks, 1 month, 3 months and every 3 months there-after post RT
Secondary	Radiographic Response	Physician documented change of tumor from pre-RT MRI as compared to 1 month post-RT MRI	1 month
Secondary	Progression Free Survival	Time to clinical, symptomatic or radiographic evidence of disease progression	Through Study Completion, an average of 1 year
Secondary	Overall Survival	Time to patient death	Through Study Completion, an average of 1 year
Secondary	Steroid Requirement	Use of steroids post-RT	Through Study Completion, an average of 1 year