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Evaluation, Treatment, and Natural History of Children With Cancer

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ClinicalTrials.gov Identifier: NCT00001686
Recruitment Status : Enrolling by invitation
First Posted : November 4, 1999
Last Update Posted : October 18, 2018
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:
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 or disease
Ewing's Sarcoma Leukemia Lymphoma Brain Tumors Rhabdomyosarcoma

Detailed Description:

Background:

Children and adults 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 and adults 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 and adults with cancer (or a pre-cancer syndrome), with disease manifestations of special interest to Pediatric Oncology Branch investigators.
  • Patients must be greater than or equal to 2 years and less than or equal to 40 years of age at the time of study enrollment.

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.


Study Type : Observational
Actual Enrollment : 444 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Children With Cancer
Actual Study Start Date : March 19, 1998


Group/Cohort
Cohort A
Children and adults with cancer (or a pre-cancer syndrome), between the age(s) of 2 years - 40 years, who present with disease manifestations of special interest to POB investigators.



Primary Outcome Measures :
  1. Evaluate children and adults with cancer [ Time Frame: End of treatment ]
    evaluate longitudinally children and adults with cancer referred to the Pediatric Oncology Branch (POB) who present with disease manifestations that lend themselves to clinical evaluation and are of unique scientific importance



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Ages Eligible for Study:   2 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adults with cancer (or a pre-cancer syndrome), between the age(s) of 2 years - 40 years, who present with disease manifestations of special interest to POB investigators.
Criteria
  • INCLUSION CRITERIA:
  • A POB, CCR investigator decides that it is in the best interest of the patient and the POB, CCR for the patient to receive treatment and follow-up at the NCI/NIH.
  • Children and adults with cancer (or a pre-cancer syndrome), between the age(s) of 2 years - 40 years (the NIH CC is not well equipped to provide optimal care to patients < 2 years of age). Note: Patients greater than or equal to 18 and less than or equal to 40 years may be evaluated on this protocol if their cancer (or precancer syndrome) is of specific interest to the POB, CCR, NCI.
  • Patients with cancer (or a pre-cancer 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, rhabdomyosarcoma.

  • Patient must weigh greater than or equal to 12 kg (the NIH CC is not well equipped to provide optimal care to patients < 12 kg)
  • The patient, parent, guardian or their Legally Authorized Representative (LAR) is able and willing to provide informed consent.
  • Patients, and when indicated, parent, guardian or LAR who are deemed sufficiently reliable to return for recommended follow-up visits.

EXCLUSION CRITERIA:

  • Patients younger than 2 years of age.
  • Patients weighing less than or equal to 12 kg.
  • Pregnant women are excluded from enrollment onto this study because the invasive procedures and/or sedation needed to perform these may cause unnecessary harm to the unborn fetus. In the event a woman becomes pregnant while on study, she will not be removed from the study; however, no invasive clinical or research procedures will be done or cancer treatment provided that include unacceptable risk to the patient and/or to the unborn fetus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001686


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Brigitte C Widemann, M.D. National Cancer Institute (NCI)

Additional Information:
ClinicalTrials.gov Identifier: NCT00001686     History of Changes
Obsolete Identifiers: NCT00445536
Other Study ID Numbers: 980037
98-C-0037
First Posted: November 4, 1999    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 5, 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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