Canadian clinical trial registry

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Study Description

This study is to assess the effectiveness of two drugs (bortezomib and vorinostat) in addition to standard therapy, for the treatment of infants with a new diagnosis of acute lymphoblastic leukemia. 

The study also looks at the side effects associated with these medications.

Bortezomib is a drug called a "proteasome inhibitor" while vorinostat is a drug called an "HDAC inhibitor".

Inclusion Criteria

• Children younger than 365 days of age with a new diagnosis of acute lymphoblastic leukemia
• They cannot have had prior treatment with other chemotherapies (with exception of a few medications, with limited amount of doses given).
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

The reason for this study is to see if the study medication LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma (neuroblastoma that has come back or is not improving despite treatment). LY3295668 erbumine blocks a protein called Aurora kinase A. Aurora kinase A is thought to contribute to the aggressiveness of neuroblastoma cells. 

The medication will be given either alone or in combination with chemotherapy.

Inclusion Criteria

• Age between 2 and 21 years
• Neuroblastoma that has come back (relapse) or is not improving despite treatments (refractory)
• The child must be able to swallow capsules
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

This is a study to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of avelumab (an antibody that binds and blocks PDL-1 on tumour cells).

This study has two parts. Part 1 will find the recommended dose for avelumab therapy and evaluate its safety. Part 2 will further evaluate the efficacy of avelumab therapy.

Inclusion Criteria

• Age between 0 and 18
• Solid malignant tumors (including brain tumors) or lymphoma for which no standard therapy is available, or with confirmed progression, or refractory to standard therapy
• Availability of tumor sample collected prior to avelumab treatment for subjects in Phase 2
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

This clinical trial studies whether adding an oral medication called lenvatinib to chemotherapy with ifosfamide/etoposide improves outcomes for patients with osteosarcoma that has come back (relapse). 

Lenvatinib blocks cell proteins and signals directed at blood vessels that help the cancer to survive.

Patients can be treated in two different arms: Arm A: chemotherapy + lenvatinib or  Arm B : chemotherapy. The participants will be divided by chance into those two separate groups through a computerised process. The treating team will NOT decide into which arm a given patient will be assigned. At this time, it is not known which treatment option is best.

Inclusion Criteria

• Age between 2 and 25 years
• Osteosarcoma that has come back (relapse) or is not improving despite treatments (refractory)
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

This is a study of two medications taken by mouth, called lenvatinib and everolimus. Lenvatinib blocks cell proteins and signals directed at blood vessels that help the cancer to survive. Everolimus is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body. It is called an mTOR inhibitor.

The phase 1 of this study has been completed, and now the phase 2 is on-going to understand the anti-cancer activity of those two medications taken together in patients with Ewing sarcoma, rhabdomyosarcoma or high grade glioma that has come back (relapsed) or is refractory to treatment.

Inclusion Criteria

• Age from 2 years to 21 years
• Diagnosis of Ewing sarcoma, rhabdomyosarcoma or high grade glioma that has come back (relapsed) or is refractory to treatment
• Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

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Study Description

Many pediatric brain and solid tumors have genetic changes that do not involve changes to the underlying DNA sequence called epigenetic alterations.These dysfunctions can favor tumour developpment. 5'Azacitidine is a drug that has similarities with one of the components of DNA and RNA.

It can kill abnormal cells through incorporation into DNA and RNA. It is expected to slow or stop the growth of cancer cells.

The aim of this phase I/II study is to evaluate the dose, safety, tolerability, antitumor activity and other characteristics of 5'azacytidine in combination with carboplatin.

Inclusion Criteria

• Greater than the age of 1 year and under age 18 at the time of study enrolment
• Recurrent or refractory solid tumor (Phase I), or recurrent or refractory ependymoma (Phase Ib)
• Tissue from diagnosis or resection prior to registration must be available (either flash frozen tissue or an FFPE (formalin fixed paraffin embedded) block)
• Previous therapy with carboplatin will be permitted
• Failed first line treatment (surgery, radiation therapy or chemotherapy) and should not be eligible for treatment with curative potential.

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

Publications

Mack SC, Witt H, Piro RM, Gu L, Zuyderduyn S, Stütz AM, Wang X, Gallo M, Garzia L, Zayne K, Zhang X, Ramaswamy V, Jäger N, Jones DT, Sill M, Pugh TJ, Ryzhova M, Wani KM, Shih DJ, Head R, Remke M, Bailey SD, Zichner T, Faria CC, Barszczyk M, Stark S, Seker-Cin H, Hutter S, Johann P, Bender S, Hovestadt V, Tzaridis T, Dubuc AM, Northcott PA, Peacock J, Bertrand KC, Agnihotri S, Cavalli FM, Clarke I, Nethery-Brokx K, Creasy CL, Verma SK, Koster J, Wu X, Yao Y, Milde T, Sin-Chan P, Zuccaro J, Lau L, Pereira S, Castelo-Branco P, Hirst M, Marra MA, Roberts SS, Fults D, Massimi L, Cho YJ, Van Meter T, Grajkowska W, Lach B, Kulozik AE, von Deimling A, Witt O, Scherer SW, Fan X, Muraszko KM, Kool M, Pomeroy SL, Gupta N, Phillips J, Huang A, Tabori U, Hawkins C, Malkin D, Kongkham PN, Weiss WA, Jabado N, Rutka JT, Bouffet E, Korbel JO, Lupien M, Aldape KD, Bader GD, Eils R, Lichter P, Dirks PB, Pfister SM, Korshunov A, Taylor MD. Epigenomic alterations define lethal CIMP-positive ependymomas of infancy. Nature. 2014 Feb 27;506(7489):445-50. doi: 10.1038/nature13108. Epub 2014 Feb 19.

Ramaswamy V, Hielscher T, Mack SC, Lassaletta A, Lin T, Pajtler KW, Jones DT, Luu B, Cavalli FM, Aldape K, Remke M, Mynarek M, Rutkowski S, Gururangan S, McLendon RE, Lipp ES, Dunham C, Hukin J, Eisenstat DD, Fulton D, van Landeghem FK, Santi M, van Veelen ML, Van Meir EG, Osuka S, Fan X, Muraszko KM, Tirapelli DP, Oba-Shinjo SM, Marie SK, Carlotti CG, Lee JY, Rao AA, Giannini C, Faria CC, Nunes S, Mora J, Hamilton RL, Hauser P, Jabado N, Petrecca K, Jung S, Massimi L, Zollo M, Cinalli G, Bognár L, Klekner A, Hortobágyi T, Leary S, Ermoian RP, Olson JM, Leonard JR, Gardner C, Grajkowska WA, Chambless LB, Cain J, Eberhart CG, Ahsan S, Massimino M, Giangaspero F, Buttarelli FR, Packer RJ, Emery L, Yong WH, Soto H, Liau LM, Everson R, Grossbach A, Shalaby T, Grotzer M, Karajannis MA, Zagzag D, Wheeler H, von Hoff K, Alonso MM, Tuñon T, Schüller U, Zitterbart K, Sterba J, Chan JA, Guzman M, Elbabaa SK, Colman H, Dhall G, Fisher PG, Fouladi M, Gajjar A, Goldman S, Hwang E, Kool M, Ladha H, Vera-Bolanos E, Wani K, Lieberman F, Mikkelsen T, Omuro AM, Pollack IF, Prados M, Robins HI, Soffietti R, Wu J, Metellus P, Tabori U, Bartels U, Bouffet E, Hawkins CE, Rutka JT, Dirks P, Pfister SM, Merchant TE, Gilbert MR, Armstrong TS, Korshunov A, Ellison DW, Taylor MD. Therapeutic Impact of Cytoreductive Surgery and Irradiation of Posterior Fossa Ependymoma in the Molecular Era: A Retrospective Multicohort Analysis. J Clin Oncol. 2016 Jul 20;34(21):2468-77. doi: 10.1200/JCO.2015.65.7825. Epub 2016 Jun 6.

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Study Description

Some diseases such as cancer with BRAF mutations, low grade gliomas and plexiform neurofibroma in patients with neurofibromatosis type 1 [NF-1], or Langerhans cell histocytosis [LCH]) have been shown to have molecular dysfunction called MAPK pathway dysregulation which favors tumour development. The MAPK pathway is involved in cell growth, differentiation, inflammation and apoptosis.Trametinib is an inhibitor of components of the MAPK pathway called MEK1 and MEK2. Drabafenib is a small molecule that inhibits the MAPK pathway in BRAF mutated cells by blocking the BRAF serine-threonine kinase. Both are expected to slow or stop the growth of cancer cells.

The aim of this phase I/II study is to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of Trametinib alone or with Dabrafenib in children with refractory or relapsed solid cancer or disease with BRAF mutations for which no standard therapy is available or for which the subject is not eligible for the existing therapy.

The study is currently open for LCH and neuroblastoma only.

Inclusion Criteria

• Male or female between one month and <18 years of age (inclusive) at the time of signing consent
• Must have a disease that is relapsed/refractory to all potentially curative standard treatment regimens or must have a current disease for which there is no known curative therapy, or therapy proven to prolong survival with an acceptable quality of life.
• The subject's disease (i.e. cancer, neurofibromatosis type 1 [NF-1] with plexiform neurofibroma [PN], or Langerhans cell histocytosis [LCH]) must have relapsed after or failed to respond to frontline curative therapy or there must not be other potentially curative treatment options available. Curative therapy may include surgery, radiation therapy, chemotherapy, or any combination of these modalities
• Able to swallow and retain enterally administered medication

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

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Study Description

Some rare cancer such as rhabdoid tumors or epithelioid sarcoma have been shown to have a molecular dysfunction allowing a protein called EZH2 to favour tumour developpment. Tazemetostat is an EZH2 inhibitor and is expected to slow or stop the growth of cancer cells. The aim of this Phase I study is to evaluate the dose, safety, tolerability, antitumor activity and other pharmacologic characteristics of Tazemetostat in children with refractory or relapsed solid cancer  for which no standard therapy is available or for which the subject is not eligible for the existing therapy. 

Inclusion Criteria

• Age ≥6 months to <18 years
• Patient has one of the specific disease targeted in this study, histologically confirmed by a CLIA/CAP certified laboratory
• Relapsed or refractory disease and no standard treatment options as determined by locally or regionally available standards of care and treating physician's discretion
• Patient is able to swallow and retain orally administered medication

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.