Late Effects After Treatment in Patients With Previously Diagnosed High-Risk Neuroblastoma

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    400
  • sponsor
    Children's Oncology Group
Send
Updated on 25 December 2020
See if I qualify
Investigator
Joseph M. Wiley
Primary Contact
Sinai Hospital of Baltimore (7.7 mi away) Contact
+73 other location
high-risk neuroblastoma

Summary

This research trial studies late effects after treatment in patients with previously diagnosed high-risk neuroblastoma. Studying late effects after treatment may help to decide which treatments for high-risk neuroblastoma are better tolerated with less side effects over time.

Description

PRIMARY OBJECTIVES:

I. To estimate the prevalence of organ dysfunction, subsequent malignant neoplasm (SMN), growth impairment, abnormal pubertal development, and neurobehavioral dysfunction in a large cohort of representative 5-year survivors of high-risk neuroblastoma treated with modern therapy.

II. To identify the demographic, clinical and treatment-related risk factors associated with increased risk of organ dysfunction, SMN, growth impairment, abnormal pubertal development and neurobehavioral dysfunction in long-term survivors of high-risk neuroblastoma.

III. To explore the impact of new biologic therapies and diagnostics including immunotherapy, immunocytokines, isotretinoin (cis-retinoic acid) and iobenguane I-131 (131 I-MIBG) on the risk of late effects.

IV. To determine the impact of impaired organ function, physical growth, pubertal development, and neurobehavioral function on health-related quality of life (HRQOL) in long-term survivors of high-risk neuroblastoma.

SECONDARY OBJECTIVES:

I. To establish a cohort of high-risk neuroblastoma survivors, with stored peripheral blood samples, who were treated with multi-modal therapies since the year 2000 as a resource for future investigation.

OUTLINE

Patients undergo collection of blood and urine samples on day 1. Patients also undergo clinical assessments, laboratory, radiographic, and other ancillary studies on day 1.

Details
Treatment laboratory biomarker analysis, quality-of-life assessment, cytology specimen collection procedure
Clinical Study IdentifierNCT03057626
SponsorChildren's Oncology Group
Last Modified on25 December 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 5 yrs and 50 yrs?
Gender: Male or Female
Do you have any of these conditions: Stage 3 Neuroblastoma or Stage 2B Neuroblastoma or Recurrent Neuroblastoma or Stage 4S Neuroblastoma or Stage 4 Neuroblastoma or Stage 2A Neuroblastom...?
Do you have any of these conditions: Recurrent Neuroblastoma or Metastatic Neuroblastoma or Stage 2A Neuroblastoma or Stage 4S Neuroblastoma or Stage 2B Neuroblastoma or Stage 3 Neuroblas...?
Do you have any of these conditions: Stage 4 Neuroblastoma or Stage 2A Neuroblastoma or Stage 3 Neuroblastoma or Stage 4S Neuroblastoma or Recurrent Neuroblastoma or Metastatic Neuroblast...?
Do you have any of these conditions: Stage 3 Neuroblastoma or Stage 2A Neuroblastoma or Stage 4S Neuroblastoma or Stage 4 Neuroblastoma or Recurrent Neuroblastoma or Stage 2B Neuroblastom...?
Do you have any of these conditions: Stage 2A Neuroblastoma or Stage 4S Neuroblastoma or Metastatic Neuroblastoma or Stage 3 Neuroblastoma or Stage 2B Neuroblastoma or Stage 4 Neuroblasto...?
Patients must have been enrolled on COG neuroblastoma biology study ANBL00B1
Patient must have been diagnosed with high-risk neuroblastoma per ANBL00B1 definition
Patient must have been diagnosed on or after January 1, 2000
At least 5 years must have elapsed since diagnosis
Patients must have been treated for high-risk neuroblastoma
Note: patients may have had any therapy for high-risk neuroblastoma, including second line or non-established therapies (for example in the setting of less than optimal initial response or concerns for high risk of relapse); patients may have received therapy for refractory or relapsed neuroblastoma, or treatment for an SMN; however all cytotoxic anti-neuroblastoma therapy should have been administered >= 2 years of the enrollment date; SMN therapy may be completed or ongoing at the time of enrollment

Exclusion Criteria

Patients must not be currently receiving active anti-neuroblastoma cytotoxic chemotherapy
Patients must not have received anti-neuroblastoma cytotoxic chemotherapy within the last two years
Note: cytotoxic therapies include (but are not limited to) chemotherapy (platinum agents, alkylators, anthracyclines, topoisomerases, vinca alkaloids, other cytotoxic chemotherapy), any kind of transplant, MIBG therapy, and/or radiation therapy
Non-cytotoxic (biologic/targeted/differentiating/other) therapies are permitted at the time of enrollment; for example, patients receiving oral differentiating agents, antiangiogenic therapy, immune modulators, holistic therapies, difluoromethylornithine (DMFO), other minimal residual disease (MRD) therapies/relapse-prevention therapies are eligible
Patients with current active neuroblastoma relapse are ineligible
Clear my responses
Read more

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name
Edit Delete

Annotated by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No made yet