Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

Chronic and Late Effects of Non-Hodgkin's Lymphoma and Its Treatment in Long Term Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001301
• Other study ID #: 920242
• Secondary ID: 92-C-0242
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: August 1992
• Est. completion date: April 2000

Study information

• Verified date: June 1999
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during which time a number of different treatment protocols have been used. Approximately 110 patients have apparently been cured of their lymphoma. The present protocol has no therapeutic component, but is designed to document the late effects that may have been encountered by our patients, either as a consequence of the disease or its treatment. In essence, patients who consent to participate will be asked a series of questions pertaining to the quality of their life and possible medical problems that they may be encountering. In addition, they will receive a complete physical examination and undergo non-invasive investigations designed to identify the presence of unsuspected late effects. Investigators in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will participate in the protocol. As a part of the study, blood samples will be obtained to investigate the possibility that predisposing genetic factors may be identifiable in the patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such abnormalities are detected, blood samples from family members will also be examined to determine whether the defect was inherited.

Description:

Non-Hodgkin's lymphoma has been studied in the Pediatric Branch for at least 20 years, during which time a number of different treatment protocols have been used. Approximately 110 patients have apparently been cured of their lymphoma. The present protocol has no therapeutic component, but is designed to document the late effects that may have been encountered by our patients, either as a consequence of the disease or its treatment. In essence, patients who consent to participate will be asked a series of questions pertaining to the quality of their life and possible medical problems that they may be encountering. In addition, they will receive a complete physical examination and undergo non-invasive investigations designed to identify the presence of unsuspected late effects. Investigators in the Eye Clinic, Dental Clinic, Audiology, Cardiology and Endocrinology departments will participate in the protocol. As a part of the study, blood samples will be obtained to investigate the possibility that predisposing genetic factors may be identifiable in the patients normal cells (e.g., p53 mutations, evidence of DNA instability). If such abnormalities are detected, blood samples from family members will also be examined to determine whether the defect was inherited.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Patients with a histologic diagnosis of small noncleaved cell (undifferentiated) (SNCL), lymphoblastic (LL), and large cell lymphoma (LCL) who were treated according to National Cancer Institute Pediatric Branch non-Hodgkin's lymphoma protocols 74-0, 75-6, 76-5, 77-04, 85-C-67, and 89-C-41A, and who have been in continuous remission for one year or longer following completion of treatment.

Patients who have relapsed and been successfully re-treated are not excluded, except for patients with lymphoblastic lymphoma who have been re-treated according to acute lymphoblastic leukemia protocols.

Study Design

N/A

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Appelbaum FR, Deisseroth AB, Graw RG Jr, Herzig GP, Levine AS, Magrath IT, Pizzo PA, Poplack DG, Ziegler JL. Prolonged complete remission following high dose chemotherapy of Burkitt's lymphoma in relapse. Cancer. 1978 Mar;41(3):1059-63. — View Citation

Magrath IT, Janus C, Edwards BK, Spiegel R, Jaffe ES, Berard CW, Miliauskas J, Morris K, Barnwell R. An effective therapy for both undifferentiated (including Burkitt's) lymphomas and lymphoblastic lymphomas in children and young adults. Blood. 1984 May;63(5):1102-11. — View Citation

Ziegler JL, DeVita VT, Graw RG Jr, Herzig G, Leventhal BG, Levine AS, Pomeroy TC. Combined modality treatment of American Burkitt's lymphoma. Cancer. 1976 Dec;38(6):2225-31. — View Citation