Chemotherapy With or Without Radiation, Low and Intermediate Risk Hodgkins Lymphoma, TXCH-HD-12A

• Status: Active, not recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Subjects have a type of cancer called Hodgkin Disease (HD), a cancer of the lymph system. The lymph system is made up of tissue throughout the body that makes and stores infection-fighting cells. HD is one of the most treatable childhood cancers. The standard treatment for HD involves chemotherapy (treatment with anti-cancer drugs) and radiation therapy (the use of high-dose x-rays to get rid of cancer cells). Although they are cured from their cancer, some patients experience negative side effects from treatment later in life. These kinds of side effects are often referred to as late effects. This can include problems with growth, problems with some organ functions, and sometimes second cancers. These types of effects can be associated with either chemotherapy or radiation therapy. The investigators are therefore designing studies to minimize or prevent these late effects. It is thought that if some patients can be successfully treated without radiation, those patients might experience fewer late side effects.

Some patients, however, do not respond as well to the first stages of treatment (slow early responders). Slow early responders are considered to be at higher risk for relapse. This study also looks at whether these kinds of patients will benefit from additional chemotherapy.

The purpose of this study is to look at how the immune system recovers and at how certain T-cells in the blood behave after receiving chemotherapy with or without radiation. The investigators also want to identify if bio-markers (special proteins in blood and in cancer) relate to the response of HD to study treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Texas Children's Hospital
• Treatments: BB 1101; Bleomycin; Cisplatin; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Etoposide; Etoposide phosphate; Liposomal doxorubicin; Prednisone; Vincristine

Criteria

Inclusion Criteria:

Patients with newly diagnosed, histologically confirmed Hodgkin Lymphoma (HD) who meet the following criteria:

• Stage IA and IB (non-bulky nodular lymphocyte predominant)

• Stage IIA and IIB

• Stage IIIA

• Stage IVA

Exclusion Criteria:

• Patients with Stage IA-IIA non-bulky lymphocyte predominant histology

• Patients who have received previous chemotherapy or radiation therapy (does NOT include steroids).

• Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction <27%).

• Patients with severe renal disease (i.e. Measured or estimated creatinine clearance or radioisotope GFR <= 70 ml/min/1.73 m2).

• Patients with pre-existing severe restrictive pulmonary disease (FVC less than 60% of predicted).

• Patients with severe hepatic disease (direct bilirubin greater than 3 mg/dl or AST greater than 500 IU/L).

• Known HIV positivity

• Patients with a Karnofsky performance score <70% or Lansky score <70%.

• Female patients who are pregnant or breast feeding.