Trial Information

Evaluation of Late Treatment Effects in Long-Term Survivors of Hodgkin's Disease Previously Treated at NIH: A Multi-Institutional Trial

BACKGROUND:

Nearly 75% of Hodgkin's Disease (HD) patients can be cured of their disease with
chemotherapy and radiotherapy, resulting in a growing number of long-term survivors.

Adverse effects of HD treatments, including second malignancies and cardiovascular disease,
affect survival and quality of life. Minimizing late toxicities has become a major emphasis
of current and investigational regimens.

Better characterization of long-term toxicity and quality of life (QOL) after therapy for HD
and the ability to determine which late toxicities arise from a given modality may allow an
ability to shape future regimens such that late toxicity can be minimized.

OBJECTIVES:

Primary objectives:

To describe the cardiac, pulmonary, and vascular function in patients previously treated for
HD at NIH and to correlate this information to the treatment received.

- To measure cardiac function and abnormalities and to correlate these findings with
treatment received.

- To measure pulmonary function with pulmonary function testing in survivors of HD and to
correlate these findings with treatment received.

- To measure vascular function in survivors of HD and to correlate these findings with
treatment received.

Secondary Objectives:

To determine if elevated plasma TGF levels correlate with the presence of late radiation
fibrosis in long-term survivors of HD.

To evaluate late quality of life (QOL) in long-term survivors of HD and to correlate QOL
with treatment received.

To evaluate and describe additional exploratory measures of organ function in patients
previously treated for HD at NIH and to correlate this information to the treatment
received.

- Heart rate variability

- Pulmonary fibrosis.

- Intestinal function.

- Neurocognitive function.

To evaluate the correlation of exploratory functional assays, biomarkers, and single
nucleotide polymorphisms with the presence of late chemotherapy or radiation toxicity in
long-term HD survivors.

ELIGIBILITY:

Survivors of HD previously treated at the NIH.

DESIGN:

This is a single point in time follow-up evaluation of long-term HD survivors, previously
treated at the NIH.

Patients will be evaluated for late toxicities in multiple organ systems using imaging
modalities, laboratory tests, functional assays, and investigational studies.