paediatric patients, intermediate risk hodgkin disease, Hodgkin.
Conditions
Interventions
The standard arm for this protocol will be 4 cycles of ABVE-PC plus consolidative involved field radiation therapy. Slow early responders will be randomized to either the standard arm, or the augmente
Sponsors
The Children's Oncology Group, USA
Eligibility
Inclusion criteria
Inclusion criteria: - Patients with newly diagnosed, pathologically confirmed Hodgkin disease (all histologies) are eligible for this protocol if they meet the following clinical stage guidelines: 1. All Stage IB regardless of bulk disease 2. All Stage IIB regardless of bulk disease 3. Stage IA only with bulk disease 4. Stage IIA only with bulk disease 5. All Stage IAE, IIAE regardless of bulk disease 6. All Stage IIIA, IIIAE, IIIAS, IIIAE+S regardless of bulk disease 7. All Stage IVA, IVAE regardless of bulk disease See Appendix I of the protocol for definitions of clinical staging, E criteria, B symptoms and bulk disease. Clinical Staging Staging on this study will be determined by the clinical stage. Patients who have surgical staging (by laparotomy) alone are ineligible for entry on this protocol. Surgically staged patients may be entered on this study if they also have pre-surgical staging that meets the above criteria. Surgical staging is strongly discouraged. 8. Ages 0 - 21 years inclusive. 9. Organ Function Requirements - Adequate renal function defined as: * Creatinine clearance or radioisotope GFR ³ 70mL/min/1.73m2 or * A serum/plasma creatinine calculation using the Schwartz formula (Schwartz et al. J. Peds, 106:522, 1985) Estimated Creatinine Clearance (in mL/min/1.73 m2)** = (k)(L)/Pcr Where L = child’s length in cm Pcr = plasma (or serum) creatinine (in mg/dL) k Values = 0.33 low birth weight infant 0.45 term infant 0.55 child 0.55 adolescent female 0.70 adolescent male **The conversion formula for serum/plasma creatinine when reported in Mol/L units: (k • ht)/(sCr in Mol/L • 88.4) * Adequate liver function defined as: -Total bilirubin ≤ 1.5 x normal, and - SGOT (AST) or SGPT (ALT) 60% by pulmonary function test, unless due to large mediastinal mass from HD. Study chair approval required for entry onto protocol with FEV1/FVC≤ 60% - For children who cannot adequately perform PFTs, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94%. PFTs should not be attempted for children under the age of 7 years. Patients with other pre-existing cardiac or pulmonary abnormalities require Study Chair approval prior to being placed on therapy. 10. Women who are pregnant or breast-feeding will not be eligible. 11. Previous therapies. Patients may not have received any previous chemotherapy, biological modifiers such as monoclonal antibody therapy or radiation therapy. Patients may not have received corticosteroids within 28 days of enrollment on this protocol, except as specified in Section 5.1 for emergent treatment for respiratory distress or spinal cord compression, or for treatment of contrast agent allergy required for CT scan
Exclusion criteria
Exclusion criteria: Criteria for case exclusion include: 1. Equivocal immunophenotyping results 2. Morphologically unclassifiable lymphoma 3. Pathology review diagnosis not included in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy endpoints. The primary endpoint for efficacy analysis is event-free survival (EFS), which is the minimum time from study entry, time of response assessment, or randomization (as appropriate) until treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. The patients to be included in the analyses for Aim 1.12 (=To determine whether involved field radiation therapy (IFRT) can be eliminated based upon early and complete response to multiagent chemotherapy.) are the cohort of all RER patients who are randomized. The patients to be included in the analyses for Aim 1.13 (=To determine whether the addition of an additional two cycles of chemotherapy (DECA) can improve outcome in those with a slow early response to standard chemotherapy.) are the cohort of all SER patients who are randomized. These analyses will include randomized patients with protocol violations and randomized patients removed for protocol therapy. However, patients who are determined to be ineligible based on the study eligibility/entry criteria will be excluded. Toxicity endpoints. The primary endpoint for toxicity analysis will be occurrence of any key toxicity, which in this study is the occurrence of any Grade 4 non-haematologic toxicity, or Grade 3 non-haematologic toxicity that doesn’t respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Exceptions are Grade 3 nausea, vomiting or liver function abnormalities that return to Grade  2 within 7 days. All treated patients will be included in the toxicity analyses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints are overall survival (OS) and disease response. | — |
Contacts
Public ContactK.M. Pal, van der-de Bruin
TNO Quality of Life, P.O. Box 2215
Outcome results
None listed