Vincristine for Cancer

Not currently recruiting at 30 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Oncology Group

Must be taking: Vincristine

Must not be taking: Azoles, Macrolides, CYP3A4/5 inducers

Disqualifiers: Charcot-Marie-Tooth, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new dosing method for vincristine, a cancer drug, specifically for infants and young children. Researchers aim to determine if this method results in similar drug exposure levels in the blood as the standard method used in older children. The study involves collecting blood samples at specific times to measure the drug concentration in the bloodstream. Infants and young children with cancer who receive vincristine as part of their treatment might be suitable candidates, especially if they have experienced severe side effects with traditional dosing methods. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, contributing to advancements in pediatric cancer care.

Do I have to stop taking my current medications for the trial?

You may need to stop certain medications before joining the trial. Specifically, you cannot take azole antifungals, macrolide antibiotics, or medications that affect the CYP3A4/5 enzyme. If you're on these, you'll need to stop them 14 days before starting the trial.

What prior data suggests that this new dosing method for vincristine is safe for infants and young children?

Research has shown that vincristine is usually well-tolerated in children. As an FDA-approved treatment for neuroblastoma, its safety has been thoroughly studied in this population. However, vincristine can cause some side effects, such as hair loss and possible tissue damage if the drug leaks from the vein. Although these effects might be concerning, they are known and monitored during treatment. This trial tests a new dosing method to better suit infants and young children, potentially helping them handle the drug more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Vincristine is unique because researchers are exploring how it behaves specifically in infants, which is not well understood yet. While vincristine is already a standard treatment for various cancers, this trial aims to understand its pharmacokinetics—how the drug is absorbed, distributed, metabolized, and excreted—specifically in infants. This could lead to more effective dosing and potentially better outcomes for young patients, making researchers excited about the potential to tailor cancer treatments more precisely for infants.

What evidence suggests that this new dosing method for vincristine is effective for cancer in young children?

Research has shown that vincristine treats various childhood cancers by stopping cancer cells from growing and spreading. The FDA has approved it for treating neuroblastoma, a cancer often found in children. Studies have identified vincristine as a key part of cancer treatment plans, leading to better patient outcomes. Although limited information exists on its use in infants and young children, its success in older children suggests it could also help younger patients when the dose is carefully adjusted. Researchers are developing new methods to ensure safe and effective dosing for the youngest patients. Participants in this trial will receive vincristine as part of their standard care, and researchers will collect biospecimens to study its effects further. ^{4 6 7 8 9}

Who Is on the Research Team?

Emily Blauel

Principal Investigator

Pediatric Early Phase Clinical Trial Network

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients with a BSA < 0.6 m^2 must be dosed according to the Children's Oncology Group (COG) BSA-banded infant dosing table for the 1.5mg/m2 dose level for vinCRIStine

Note: Patients can be studied after any dose of vinCRIStine

0 to 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vincristine intravenously per standard of care with blood samples collected at specified intervals

6 weeks

Weekly visits for vincristine administration and blood sample collection

Follow-up

Participants are monitored for dose modifications and pharmacokinetic analysis

42 days

What Are the Treatments Tested in This Trial?

Interventions

• Vincristine

How Is the Trial Designed?

Group I: Observational (SOC vincristine, biospecimen collection) Experimental Treatment 2 Interventions

Patients receive vincristine IV per SOC. Patients undergo collection of blood samples at baseline (before first vincristine dose), and 2, 6-8, and 18-24 hours after a dose of vincristine. Patients may also undergo collection of blood samples with a second SOC vincristine dose at the same time points.

Vincristine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Vincristine for:

• Acute lymphocytic leukemia
• Hodgkin's disease
• Non-Hodgkin's lymphoma
• Rhabdomyosarcoma
• Neuroblastoma
• Wilms' tumor

Approved in European Union as Vincristine for:

• Acute lymphoblastic leukaemia
• Hodgkin's disease
• Non-Hodgkin's lymphoma
• Rhabdomyosarcoma
• Neuroblastoma
• Wilms' tumour

Approved in Canada as Vincristine for:

• Acute lymphocytic leukemia
• Hodgkin's disease
• Non-Hodgkin's lymphoma
• Rhabdomyosarcoma
• Neuroblastoma
• Wilms' tumor

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. oncolink.org oncolink.org/cancer-treatment/oncolink-rx/vincristine-oncovin-R-vincasar-pfs-R-vcr

Vincristine (Oncovin®, Vincasar PFS®, VCR) These medications work by interfering with cell division, which leaves the tumor unable to grow and spread. Vincristine was developed from the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7045084/

A randomised phase II trial (ISRCTN53643604) Although the trial was not powered to compare efficacy outcomes, a trend suggesting a PFS benefit was observed (3-year PFS 56% vs 39% on BEP, HR = 0.59, p = ...

3. seer.cancer.gov seer.cancer.gov/oncologytoolbox/canmed/ndconc/00703-4402/

00703-4402 Vincasar PFS - CanMED: NDC - SEER CanMED: NDC. The Cancer Medications Enquiry Database (CanMED) is a two-part resource for cancer drug treatment related studies.

4. ashpublications.org ashpublications.org/bloodneoplasia/article/2/2/100077/535620/Prognostic-impact-of-RDI-of-vincristine-in

Prognostic impact of RDI of vincristine in patients with DLBCL ... VCR dose reduction was not significantly associated with poor PFS in patients with DLBCL treated with R-CHOP, based on data from JCOG0601.

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2015/125516Orig1s000ODMemo.pdf

125516Orig1s000 - accessdata.fda.gov Vincasar PFS (vincristine sulfate PFS) was approved on July 17, 1987. It is FDA-approved for the treatment of neuroblastoma.

6. rxlist.com rxlist.com/vincasar-pfs-drug.htm

Vincasar PFS (Vincristine Sulfate Injection) There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while receiving ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/vincristine-intravenous-route/description/drg-20066703

Vincristine (intravenous route) - Side effects & dosage Other effects, such as hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used. Before ...

8. drugs.com drugs.com/sfx/vincasar-pfs-side-effects.html

Vincasar PFS Side Effects: Common, Severe, Long Term If vincristine accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or ...

9. tevausa.com tevausa.com/our-products/tevagenerics/teva-generics-catalog/vision-product-page/vincasarpfs(vincristinesulfateinjectionusp)

Vincasar PFS® (vincristine sulfate injection USP) Key Attributes. The vial and vial stopper are not made with natural rubber latex. Preservative Free. Package Details. Single-Use vial. NDC 00703-4402-11 ...