Combination Chemotherapy in Treating Patients With Lymphoma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma.

Conditions

• Lymphoma

Interventions

BIOLOGICAL

Bleomycin Sulfate (BLM)

BIOLOGICAL

Filgrastim (G-CSF)

Arm 1: Administered subcutaneously (SC) beginning on day 5 and continuing until blood counts recover through Course 1 then 2 courses administered before PBSC harvest and same regimen with Course 2, then daily with Day 0 of infusion.

BIOLOGICAL

Recombinant Interferon Alfa

DRUG

Carmustine

Arm 1, Course 3, IV over 1 hour on day -6.

DRUG

Cisplatin (CDDP)

DRUG

Cyclophosphamide

DRUG

Cytarabine (ARA-C)

Arm 1, Course 3, every 12 hours on days -5 to -2.

DRUG

Etoposide (VP-16)

Course 1, IV over 2 hours every 12 hours on days 1-3; Course 3, every 12 hours on days -5 to -2.

DRUG

Idarubicin

DRUG

Ifosfamide

During Course 1, IV continuously; Course 2, IV continuously on days 1-3.

DRUG

Leucovorin Calcium

DRUG

Melphalan

DRUG

Methotrexate

DRUG

Methylprednisolone

DRUG

mitoxantrone hydrochloride (DHAD)

Arm 1, Course 2, IV on day 1.

DRUG

Vincristine Sulfate

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Infusion of stem cells on Day 0.

RADIATION

Radiation Therapy

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Richard E. Champlin, MD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1995-10-30

Primary Completion

2004-02-04

Completion

2004-02-04

Countries

• United States

Study Locations