Dose Adjusted EPOCH-R, to Treat Mature B Cell Malignancies

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The subject is invited to take part in this research study because s/he has been diagnosed with Diffuse Large B-Cell Lymphoma (DLBCL), Primary Mediastinal B-cell Lymphoma (PMBCL), or Post-transplant Lymphoproliferative Disorder (PTLD).

In an attempt to improve cure rates while reducing harmful effects from drugs, oncologists are developing new treatment protocols. One such protocol, entitled dose-adjusted EPOCH-R, utilizes two major new strategies. First, the treatment approach utilizes continuous infusion of chemotherapy over four days, instead of being administered over minutes or hours. Secondly, the doses of some medications involved are increased or decreased based on how the drugs affect the subject's ability to produce blood cells, which is used as a measure of how rapidly the body is processing drugs.

Using this approach in adults, researchers have shown improved cure rates in these cancers. Additionally, the harmful effects experienced by patients has been mild, with mucositis, severe infections, and tumor lysis syndrome occurring rarely. However, this new dosing method has never been used in children, and the effectiveness and side effects of this new method are unknown in children.

The purpose of this study is to look at the safety of dose-adjusted EPOCH-R in the treatment of children with mature B-cell cancers, and to see if we can maintain cure rates (as has been shown in adults). This study represents the first trial of dose-adjusted EPOCH-R in children.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborators: National Cancer Institute (NCI); Texas Children's Hospital
• Treatments: Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Liposomal doxorubicin; Methotrexate; Prednisone; Rituximab; Sargramostim; Vincristine

Criteria

Inclusion Criteria:

• Patient with newly diagnosed, histologically confirmed, Group B or C diffuse large B-cell lymphoma; or primary mediastinal B-cell lymphoma. Patients with Group B/C post transplant lymphoproliferative disorder are eligible for the study regardless of whether disease is newly diagnosed. (Murphy staging will be used for group classification.)

Exclusion Criteria:

• Patient who has received previous chemotherapy or radiation therapy in the previous 3 months, except for empiric initial intrathecal administration at diagnosis. Rituximab or steroid administration is not an exclusion criterion.

• Patient who has received any prior anthracyclines.

• Patient with symptomatic cardiac failure unrelieved by medical therapy or evidence of significant cardiac dysfunction by echocardiogram (shortening fraction <28%) NOT due to mediastinal mass.

• Patient with severe renal disease (i.e. creatinine greater than 3 times normal for age; creatinine clearance less than 50 ml/min/1.73m2).

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

• Patient with a Karnofsky performance score <50% or Lansky score <50%.

• HIV-positive patients will be excluded unless antiretroviral therapy can be safely withheld during chemotherapy administration, based on clinical determination of infectious disease team evaluation.

• Female patient who is pregnant or breastfeeding.

• Patient with reproductive potential not willing to use an acceptable method of birth control (i.e. hormonal contraception, intrauterine device, condom or diaphragm with spermicide, or abstinence) for the duration of the study and one year post completion of therapy.

• Patient with primary central nervous system (CNS) lymphoma (lymphoma limited to the craniospinal axis without systemic involvement)

• Patient with Burkitt cell lymphoma or leukemia.

• Patient with group classification A disease, or group classification B stage I or II disease with normal LDH level AND tumor mass less than 7 cm.