Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma

Conditions

• Childhood Favorable Prognosis Hodgkin Lymphoma
• Childhood Lymphocyte Depletion Hodgkin Lymphoma
• Childhood Mixed Cellularity Hodgkin Lymphoma
• Childhood Nodular Sclerosis Hodgkin Lymphoma
• Stage I Childhood Hodgkin Lymphoma
• Stage II Childhood Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

N/A - 21 Years

Healthy Volunteers

Not accepted

Interventions

• radiation therapy — RADIATION
  Undergo radiation therapy
• doxorubicin hydrochloride — DRUG
  Given IV
• vincristine sulfate — DRUG
  Given IV
• prednisone — DRUG
  Given orally
• cyclophosphamide — DRUG
  Given IV
• ifosfamide — DRUG
  Given IV
• vinorelbine tartrate — DRUG
  Given IV
• dexamethasone — DRUG
  Given IV
• etoposide phosphate — DRUG
  Given IV
• cisplatin — DRUG
  Given IV
• cytarabine — DRUG
  Given IV
• filgrastim — BIOLOGICAL
  Given IV or subcutaneously

Study Details

This phase III trial is studying how well combination chemotherapy works when given before radiation therapy and/or additional chemotherapy in treating young patients with newly diagnosed Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) and giving them together with radiation therapy may kill more cancer cells.

Key Dates

Start date

Feb 28, 2006

Status verified

Aug 2016

Primary completion

Mar 31, 2012

Completion

Jun 30, 2019

Study Design

Enrollment

287 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
  Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 \& 2, Vincristine sulfate IV (1.4 mg/m2 \[max 2.8 mg\]) Days 1 \& 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 \& 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.

Primary Outcome Measure

Event Free Survival Without Receiving Radiation Therapy (EFSnoRT). [ Time Frame: At 60 months ]

Locations (1)

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