Vinblastine and Temsirolimus in Pediatric Patients With Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Canadian Cancer Trials Group
First received: January 13, 2015
Last updated: March 31, 2017
Last verified: March 2017
The purpose of this study is to determine the best dose of vinblastine that can be given with a new drug, temsirolimus.
Central Nervous System
||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||A Study of Vinblastine and Temsirolimus in Pediatric Patients With Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours
Primary Outcome Measures:
| Actual Study Start Date:
||June 2, 2015
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||February 2019 (Final data collection date for primary outcome measure)
Experimental: Vinblastine and Temsirolimus
Vinblastine starting dose:
Weight >12 kg 4mg/m^2 Weight ≤ 12 kg 0.13mg/kg IV push for 1 minute Days 1, 8, 15, 22, 29 and 36. Cycle length is 6 weeks up to 6 cycles.
Temsirolimus starting dose:
Weight >12 kg 15mg/m^2 Weight ≤ 12 kg 0.5 mg/kg IV for 1 hour on days 1, 8, 15, 22, 29 and 36. Cycle length is 6 weeks up to 6 cycles.
Vinblastine is already approved in the treatment of some types of cancer in children and temsirolimus is already used to treat some adult cancers in Canada. Temsirolimus has been shown to slow the growth of tumours in animals but it is not known if it can also slow tumour growth in children. Laboratory studies suggest that giving both vinblastine and temsirolimus may offer better results than giving vinblastine alone.
|Ages Eligible for Study:
||1 Year to 18 Years (Child, Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Patients must have histological verification of malignancy at initial diagnosis or at relapse.
Note: Histological verification is not required for patients with optic pathway gliomas, or patients with pineal tumours and elevations of CSF or serum tumour markers
- Solid tumours (excluding soft tissue sarcomas), CNS and localized brainstem tumours (excluding diffuse intrinsic pontine gliomas (DIPG)) or,
- Lymphomas including Hodgkin's disease, non-Hodgkin's lymphoma and post-transplant lymphoproliferative disease (PTLD)
- Patients must have relapsed or refractory disease for which there is no known curative therapy, with either measurable or evaluable disease
- Age ≥ 1 year and ≤ 18 years at time of registration
- Patients ≤ 16 years: Lansky ≥ 50%
- Patients ≥ 16 years: Karnofsky > 50%
Patients must have received at least one prior regimen prior to registration. There is no limit to the number of prior regimens. Patients must have recovered from the acute effects and reversible toxicities related to prior therapy and have adequate washout prior to study entry as follows:
Previous major surgery is permitted provided that it has been at least 28 days prior to registration and wound healing has occurred. Additionally, at least 7 days must have elapsed since last biopsy or other minor surgery and wound healing must have occurred.
Prior radiotherapy is permitted provided that from last dose to registration:
- At least 90 days have elapsed from total body irradiation, craniospinal radiotherapy or if ≥ 50% radiation of pelvis.
- At least 6 weeks have elapsed from other substantial bone marrow irradiation.
- At least 2 weeks have elapsed from local palliative radiotherapy (small port),
- At least 8 weeks have elapsed from 131I-MIBG therapy for neuroblastoma.
Prior myelosuppressive chemotherapy is permitted provided that it has been at least 3 weeks (6 weeks if nitrosurea) from last administration.
Prior therapy with vinblastine, mTOR inhibitors (such as temsirolimus or sirolimus) is permitted provided patients did not develop progressive disease during treatment and patients have never had to discontinue treatment due to severe adverse events such as interstitial lung disease. At least 3 weeks must have elapsed from the last administration of these agents and registration.
Patients may have received other therapies provided that an adequate time has elapsed from completion of therapy/last dose as follows:
- At least 60 days from stem cell transplant/rescue without total body irradiation and no signs of graft-versus-host disease (GVHD).
- At least 7 days (2 weeks for peg-filgrastim) from completion of therapy with hematopoietic growth factors.
- At least 3 half-lives from last administration of monoclonal antibodies.
- At least 6 weeks from any other immunotherapy (e.g. vaccines).
For biologic anti-neoplastic agents, the longer of the following must have elapsed from last administration prior to study entry: At least 2 weeks or, Standard cycle length of prior regimen or, 5 half-lives.
- Adequate Bone Marrow Function, defined as:
- Absolute neutrophil count (ANC) ≥ 1.0x10^9/L.
- Platelets ≥ 100 x 10^9/L (transfusion independent defined as not receiving platelet transfusions within 7 days prior to registration).
Hemoglobin > 80 g/L (may receive RBC transfusions). Patients with known bone marrow disease will be eligible for the study provided they meet bone marrow criteria above and they are not known to be refractory to red cell or platelet transfusions.
- Adequate Renal Function, defined as:
- Measured creatinine clearance/GFR ≥ 70 mL/min/1.73 m2 OR,
Serum creatinine ≤ 1.5 x ULN for age.
- Adequate Liver Function, defined as:
- Total bilirubin ≤ 1.5 x upper limit normal for age.
- ALT ≤ 1.5 x upper limit of normal.
Serum albumin ≥ 20 g/L.
- Adequate Metabolic Function, defined as:
- Serum triglyceride level ≤ 3.42 mmol/L (300 mg/dL).
- Serum cholesterol level ≤ 7.75 mmol/L (300 mg/dL).
- Blood glucose ≤ ULN for age. Initial sampling may be random; if abnormal, fasting blood glucose must be obtained and be within the upper normal limits for age.
Adequate Pulmonary Function, defined as:
- No dyspnea at rest.
- O2 saturations of ≥ 92% on room air.
- Patients with any baseline respiratory symptoms, or with a history of pulmonary toxicity, and who are old enough to complete pulmonary function tests, should have documented FEV1 and vital capacity ≥ 50% normal value.
- Electrolytes: ≤ grade 1 (Potassium, Calcium, Magnesium, Phosphate)
- Patient or guardian consent must be obtained on all patients according to local Institutional and/or University Human Experimentation Committee requirements. Children > 8 years old whose parent or guardian has signed consent on their behalf may also sign assent if desired
- Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre
- In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient registration
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02343718
|Children's and Women's Health Centre of BC Branch
|Vancouver, British Columbia, Canada, V6H 3V4 |
|Izaak Walton Killam (IWK) Health Centre
|Halifax, Nova Scotia, Canada, B3K 6R8 |
|McMaster Children's Hospital
|Hamilton, Ontario, Canada, L8N 3Z5 |
|Children's Hospital of Eastern Ontario
|Ottawa, Ontario, Canada, K1H 8L1 |
|Hospital for Sick Children
|Toronto, Ontario, Canada, M5G 1X8 |
|Montreal, Quebec, Canada, H3T 1C5 |
Canadian Cancer Trials Group
||Hospital for Sick Children, Toronto ON Canada
||Children's & Women's Health Centre of BC Branch, Vancouver BC, Canada
||Canadian Cancer Trials Group
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 13, 2015
||March 31, 2017
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 17, 2017
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action