Evaluation, Treatment, and Natural History of Children With Cancer

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001686
First received: November 3, 1999
Last updated: February 20, 2015
Last verified: February 2015
  Purpose

This protocol is designed to evaluate children with cancer who appear to be probable candidates for future protocol entry or have disease manifestations that are of unique scientific importance or educational value.


Condition Intervention
Ewing's Sarcoma
Leukemia
Lymphoma
Brain Tumors
Rhabdomyosarcoma
Drug: Standard of Care

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Children With Cancer

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Standard of care [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: December 1997
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Standard of Care
Drug: Standard of Care
N/A

Detailed Description:

Background:

Children are referred to the Pediatric Oncology Branch (POB) for possible enrollment in clinical protocols for the treatment of cancer. While some children are not eligible for a specific protocol, they may present with disease manifestations that offer the potential for important new insights into the pathogenesis or clinical behavior of their underlying disease. In addition, children who have completed participation in a clinical protocol but do not currently have therapeutic protocol alternatives may continue to provide POB with important information. Diseases of interest to the POB include, but are not limited to lymphoma, brain tumors, Ewings sarcoma, leukemia, neuroectodermal tumors, osteosarcoma, and rhabdomyosarcoma. Hence, serial clinical evaluation of such patients, including the performance of clinical, laboratory, and diagnostic studies to help elucidate longitudinally the underlying disease mechanisms, and when clinically indicated standard care therapies, will assist POB meet its overall mission.

Objectives:

To be able to follow and evaluate children with cancer or pre-cancer syndromes referred to the Pediatric Oncology Branch who present with disease manifestations that lend themselves to clinical evaluation and are of unique scientific import.

Eligibility:

Patients who are evaluated by the Pediatric Oncology Branch and are: Children with cancer (or a pre-cancer syndrome), between the age(s) of 3 months - 40 years who present with disease manifestations of special interest to Pediatric Oncology Branch investigators, because they are likely to shed led light on disease pathogenesis or the clinical behavior of the disorder. Patients between the ages of 30 and 40 years may be evaluated on this protocol if their cancer (or pre-cancer syndrome) is of specific interest to the Pediatric Oncology Branch.

Design:

The medical procedures or tests will be selected for each patient on the basis of his/her individual diagnosis (or presumed diagnosis). When clinically indicated, standard therapy will be administered and patients will be followed according to standard medical practice. Specimens may be collected for clinical care purposes only to evaluate the patient s status.

No investigational tests, drugs or therapies will be administered in this protocol.

  Eligibility

Ages Eligible for Study:   3 Months to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Patients who are evaluated by the Pediatric Oncology Branch and are:

Children with cancer (or a precancer syndrome), between the age(s) of 3 months to 40 years.

Patients between the ages of 30 and 40 years may be evaluated on this protocol if their cancer (or precancer syndrome) is of specific interest to the Pediatric Oncology Branch.

Patients with cancer (or a precancer syndrome), who present with disease manifestations of special interest to Pediatric Oncology Branch investigators, including but not limited to, lymphoma, brain tumors, Ewings sarcoma, leukemia, neuroectodermal tumors, osteosarcoma, rhabdomysarcoma.

If indicated, availability of a parent or legal guardian to give informed consent.

Patients, and, when indicated, parent or legal guardian who are deemed sufficiently reliable to return for recommended follow-up visits.

Patients greater than or equal to 18 years of age must be able to give informed consent.

EXCLUSION CRITERIA:

Patients younger than 3 months of age.

  Contacts and Locations
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: NCT00001686

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Crystal L Mackall, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00001686     History of Changes
Obsolete Identifiers: NCT00445536
Other Study ID Numbers: 980037, 98-C-0037
Study First Received: November 3, 1999
Last Updated: February 20, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Leukemia
Ewing's Sarcoma
Neuroectodermal Tumors
Osteosarcoma Lymphoma
Rhabdomyosarcoma Brain Tumors
Lymphoma
Neoplasm
Sarcoma

Additional relevant MeSH terms:
Brain Neoplasms
Rhabdomyosarcoma
Sarcoma, Ewing
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Myosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Nervous System Diseases
Nervous System Neoplasms
Osteosarcoma
Sarcoma

ClinicalTrials.gov processed this record on April 16, 2015