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Recurrent LymphomaPhase 1NCT02343718

Vinblastine and Temsirolimus in Pediatrics With Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours

A Phase 1 study testing Vinblastine and Temsirolimus in people with Recurrent Lymphoma and Refractory Lymphoma, run by Canadian Cancer Trials Group at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the best dose of vinblastine that can be given with a new drug, temsirolimus. Read more about this study

Who is it for?
Ages 1 year to 18 years
What is being tested?
Vinblastine and Temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
6 sitesCanada
Study dates
24 Jun 2015to 16 Jan 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
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  • Performance status:
  • Patients ≤ 16 years: Lansky ≥ 50%
  • Patients ≥ 16 years: Karnofsky > 50%
  • Prior Therapy
  • 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:
  • Surgery:
  • 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.
  • Radiation:
  • 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.
  • Chemotherapy:
  • 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.
  • Other Therapy:
  • 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

Who cannot join

  • Patients with serious illness or medical condition that would not permit the patient to be managed according to the protocol including, but not limited to:
  • Active or uncontrolled infections;
  • Uncontrolled diabetes;
  • Any other medical conditions that might be aggravated by treatment;
  • History of an underlying inherited or ongoing bleeding disorder;
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events (e.g. heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age) or mean resting corrected QT interval (QTc) > 470 msec).
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  • Patients with a history of allergic reactions or known hypersensitivity to the study drug(s) or their components, or compounds of similar chemical or biologic composition.
  • Patients with lymphoma or solid tumours (except primary CNS tumours) who have untreated brain metastases, untreated spinal cord compression or meningeal metastases are not eligible (CNS imaging is not required to rule this out unless there is a clinical suspicion of CNS disease). Patients with treated brain metastases who have radiologic evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic. If being treated with corticosteroids, must be at a stable or decreasing dose for at least 7 days prior to study entry.
  • Concurrent Medications
  • Patients receiving other investigational agents.
  • Patients receiving other anti-cancer agents, or radiation therapy.
  • Patients receiving angiotensin-converting enzyme (ACE) inhibitors.
  • Patients receiving QT/QTc-prolonging drugs.
  • Patients receiving anticoagulants.
  • Patients receiving anti-GVHD or agents to prevent organ rejection post-transplant.
  • Patients receiving strong/potent CYP3A4/5 substrates/inhibitors/inducers. These agents must have been discontinued for at least 14 days prior to registration. Grapefruit juice is also not permitted for at least 14 days prior to registration and at any time during study participation.
  • Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use a highly effective contraceptive method. Pregnant or breast feeding females will not be entered on this study due to the potential fetal and teratogenic adverse events.
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • Izaak Walton Killam (IWK) Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • McMaster Children's Hospital

    Hamilton, Ontario, L8N 3Z5

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • Children's and Women's Health Centre of BC Branch

    Vancouver, British Columbia, V6H 3V4

Other trials in Canada

About this study

Official title: A Study of Vinblastine and Temsirolimus in Pediatric Patients With Recurrent or Refractory Lymphoma or Solid Tumours Including CNS Tumours

The purpose of this study is to determine the best dose of vinblastine that can be given with a new drug, temsirolimus.

Read the detailed description

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.

Being tested
Vinblastine, Temsirolimus
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VinblastineDrug

  • TemsirolimusDrug

Study groups in NCT02343718
Study groupRoleWhat they receive
Vinblastine and TemsirolimusExperimentalVinblastine 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.
Receives: Drug: Vinblastine; Drug: Temsirolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    To determine the recommended phase II dose (RP2D) of the combination of vinblastine and temsirolimus (administered as a weekly intravenous dose) in children with recurrent or refractory solid tumours including central nervous system (CNS) tumours and lymphoma and to describe the associated toxicities in children

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2015 (estimated)
  2. Study start24 Jun 2015
  3. Primary completion28 Sep 2017
  4. Study completion16 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02343718
Sponsor's protocol ID
I218
Status last verified
Apr 2020
First submitted
13 Jan 2015
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Deyell RJ, Wu B, Rassekh SR, Tu D, Samson Y, Fleming A, Bouffet E, Sun X, Powers J, Seymour L, Baruchel S, Morgenstern DA. Phase I study of vinblastine and temsirolimus in pediatric patients with recurrent or refractory solid tumors: Canadian Cancer Trials Group Study IND.218. Pediatr Blood Cancer. 2019 Mar;66(3):e27540. doi: 10.1002/pbc.27540. Epub 2018 Nov 4.

    PubMed 30393943

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vinblastine and Temsirolimus in people with Recurrent Lymphoma and Refractory Lymphoma, run by Canadian Cancer Trials Group at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 52 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02343718, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.

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