NCT00025259

Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00025259

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease

Summary

This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.

Eligibility

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:

* All Stage IB regardless of bulk disease
* All Stage IIB regardless of bulk disease
* Stage IA only with bulk disease
* Stage IIA only with bulk disease
* All Stage IAE, IIAE regardless of bulk disease
* All Stage IIIA, IIIAE, IIIAS, IIIAE+S regardless of bulk disease
* All Stage IVA, IVAE regardless of bulk disease
* May not be staged by laparotomy alone

* Surgically staged patients must also have presurgical staging
* Bilirubin no greater than 1.5 times normal
* SGOT or SGPT less than 2.5 times normal
* Creatinine no greater than 1.5 times normal
* Creatinine clearance greater than 40 mL/min
* Radioisotope glomerular filtration rate greater than 70 mL/min
* Shortening fraction at least 27% by echocardiogram
* Ejection fraction at least 50% by MUGA
* No pathologic prolongation of QTc interval on 12-lead electrocardiogram
* FEV_1/FVC greater than 60% by pulmonary function test
* Pulse oximetry greater than 94%
* No evidence of dyspnea at rest
* No exercise intolerance
* Adequate venous access
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chemotherapy
* At least 1 month since prior corticosteroids except prednisone for respiratory distress
* No prior radiotherapy

Disease(s) and\or Condition(s)

Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma

Childhood Mixed Cellularity Classical Hodgkin Lymphoma

Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma

Childhood Nodular Sclerosis Classical Hodgkin Lymphoma

Stage I Childhood Hodgkin Lymphoma

Stage II Childhood Hodgkin Lymphoma

Stage III Childhood Hodgkin Lymphoma

Stage IV Childhood Hodgkin Lymphoma

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: Bleomycin Sulfate
- Description: Given IV or SC
- Arm Group Labels: Arm I (Patients off-therapy before callback-Induction only), Arm II (RER with CR [ABVE-PC, IFRT]), Arm III (RER with CR [ABVE-PC]), Arm IV (RER with less than CR [ABVE-PC, IFRT]), Arm V (RER with PD), Arm VI (SER [DECA, ABVE-PC, IFRT]), Arm VII (SER [ABVE-PC, IFRT])
- Type: DRUG
- Name: Cisplatin
- Description: Given IV
- Arm Group Labels: Arm VI (SER [DECA, ABVE-PC, IFRT])
- Type: DRUG
- Name: Cyclophosphamide
- Description: Given IV
- Arm Group Labels: Arm I (Patients off-therapy before callback-Induction only), Arm II (RER with CR [ABVE-PC, IFRT]), Arm III (RER with CR [ABVE-PC]), Arm IV (RER with less than CR [ABVE-PC, IFRT]), Arm V (RER with PD), Arm VI (SER [DECA, ABVE-PC, IFRT]), Arm VII (SER [ABVE-PC, IFRT])
- Type: DRUG
- Name: Cytarabine
- Description: Given IV
- Arm Group Labels: Arm VI (SER [DECA, ABVE-PC, IFRT])
- Type: DRUG
- Name: Dexamethasone
- Description: Given IV
- Arm Group Labels: Arm VI (SER [DECA, ABVE-PC, IFRT])
- Type: DRUG
- Name: Doxorubicin Hydrochloride
- Description: Given IV
- Arm Group Labels: Arm I (Patients off-therapy before callback-Induction only), Arm II (RER with CR [ABVE-PC, IFRT]), Arm III (RER with CR [ABVE-PC]), Arm IV (RER with less than CR [ABVE-PC, IFRT]), Arm V (RER with PD), Arm VI (SER [DECA, ABVE-PC, IFRT]), Arm VII (SER [ABVE-PC, IFRT])
- Type: DRUG
- Name: Etoposide
- Description: Given IV
- Arm Group Labels: Arm I (Patients off-therapy before callback-Induction only), Arm II (RER with CR [ABVE-PC, IFRT]), Arm III (RER with CR [ABVE-PC]), Arm IV (RER with less than CR [ABVE-PC, IFRT]), Arm V (RER with PD), Arm VI (SER [DECA, ABVE-PC, IFRT]), Arm VII (SER [ABVE-PC, IFRT])
- Type: BIOLOGICAL
- Name: Filgrastim
- Description: Given SC
- Arm Group Labels: Arm I (Patients off-therapy before callback-Induction only), Arm II (RER with CR [ABVE-PC, IFRT]), Arm III (RER with CR [ABVE-PC]), Arm IV (RER with less than CR [ABVE-PC, IFRT]), Arm V (RER with PD), Arm VI (SER [DECA, ABVE-PC, IFRT]), Arm VII (SER [ABVE-PC, IFRT])
- Type: RADIATION
- Name: Involved-Field Radiation Therapy
- Description: Undergo IFRT
- Arm Group Labels: Arm II (RER with CR [ABVE-PC, IFRT]), Arm IV (RER with less than CR [ABVE-PC, IFRT]), Arm VI (SER [DECA, ABVE-PC, IFRT]), Arm VII (SER [ABVE-PC, IFRT])
- Type: DRUG
- Name: Prednisone
- Description: Given orally
- Arm Group Labels: Arm I (Patients off-therapy before callback-Induction only), Arm II (RER with CR [ABVE-PC, IFRT]), Arm III (RER with CR [ABVE-PC]), Arm IV (RER with less than CR [ABVE-PC, IFRT]), Arm V (RER with PD), Arm VI (SER [DECA, ABVE-PC, IFRT]), Arm VII (SER [ABVE-PC, IFRT])
- Type: DRUG
- Name: Vincristine Sulfate Liposome
- Description: Given IV
- Arm Group Labels: Arm I (Patients off-therapy before callback-Induction only), Arm II (RER with CR [ABVE-PC, IFRT]), Arm III (RER with CR [ABVE-PC]), Arm IV (RER with less than CR [ABVE-PC, IFRT]), Arm V (RER with PD), Arm VI (SER [DECA, ABVE-PC, IFRT]), Arm VII (SER [ABVE-PC, IFRT])

Sponsor

Children's Oncology Group