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Imetelstat for Children With Refractory or Recurrent Solid Tumors and Lymphoma

NCT01568632 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2012-11-21

No results posted yet for this study

Summary

Background:

\- Imetelstat is a cancer treatment drug that may slow or stop tumor growth. It may also prevent tumors from spreading to other parts of the body. Researchers want to see if it can be a safe and effective treatment for children who have solid tumors or lymphoma that have not responded to other treatments.

Objectives:

\- To see if imetelstat is a safe and effective treatment for children who have solid tumors or lymphoma that have not responded to other treatments.

Eligibility:

\- Children and adolescents between 1 and 21 years of age who have solid tumors or lymphoma that have not responded to other treatments.

Design:

* Participants will be screened with a physical exam, medical history, and imaging studies. Blood and urine samples will also be collected.
* Participants will receive imetelstat on the first and eighth day of a 21-day cycle of treatment.
* Treatment will be monitored with frequent blood tests and imaging studies. Tumor biopsies may also be performed.
* Participants will keep taking the study drugs for up to a total of 18 cycles as long as the disease does not progress and there are no severe side effects....

Conditions

Interventions

DRUG

Imetelstat

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • William L Dahut, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Completion
2012-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01568632 on ClinicalTrials.gov