Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00003389

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Hodgkin's Lymphoma

Official Title:

A Randomized Phase III Trial of ABVD Versus Stanford V (+/-) Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining more than one drug with radiation therapy may kill more cancer cells. It is not yet known which combination chemotherapy regimen is most effective in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work, with or without radiation therapy, in treating patients with Hodgkin's lymphoma.

Eligibility

Inclusion criteria:

* Histologically proven previously untreated classical Hodgkin's lymphoma
* The following stages are eligible:

* Locally extensive: Stage I-IIA/B with massive mediastinal adenopathy
* Advanced: Stage III or IV
* Measurable or evaluable disease
* Age of 16 and over
* ECOG Performance status 0-2
* Disease-free of prior invasive malignancies for >5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* White blood cell (WBC) at least 4,000/mm³, (unless documented bone marrow involvement)
* Platelet count at least 100,000/mm³ (unless documented bone marrow involvement)
* Bilirubin no greater than 5.0 mg/dL
* Creatinine no greater than 2.0 mg/dL
* Ejection fraction determination recommended if over age 50 and/or have a history of cardiac disease
* Fertile patients must use effective contraception
* Prior corticosteroids allowed
* Prior surgery allowed

Exclusion criteria:

* Pregnant or nursing
* Prior radiotherapy
* Prior chemotherapy
* Human immunodeficiency virus (HIV) positive

Disease(s) and\or Condition(s)

Lymphoma

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: Doxorubicin
    • Description: given IV
    • Arm Group Labels: Arm A (ABVD), Arm B (Stanford V)
    • Type: DRUG
    • Name: Bleomycin
    • Description: given IV
    • Arm Group Labels: Arm A (ABVD), Arm B (Stanford V)
    • Type: DRUG
    • Name: Vinblastine
    • Description: given IV
    • Arm Group Labels: Arm A (ABVD), Arm B (Stanford V)
    • Type: DRUG
    • Name: Dacarbazine
    • Description: given IV
    • Arm Group Labels: Arm A (ABVD)
    • Type: DRUG
    • Name: Vincristine
    • Description: given IV
    • Arm Group Labels: Arm B (Stanford V)
    • Type: DRUG
    • Name: Mechlorethamine
    • Description: given IV
    • Arm Group Labels: Arm B (Stanford V)
    • Type: DRUG
    • Name: Etoposide
    • Description: given IV
    • Arm Group Labels: Arm B (Stanford V)
    • Type: DRUG
    • Name: Prednisone
    • Description: taken orally
    • Arm Group Labels: Arm B (Stanford V)
    • Type: DRUG
    • Name: Cyclophosphamide
    • Description: given IV
    • Arm Group Labels: Arm B (Stanford V)
    • Type: RADIATION
    • Name: Radiotherapy
    • Description:
    • Arm Group Labels: Arm A (ABVD), Arm B (Stanford V)
Sponsor
  • Eastern Cooperative Oncology Group