Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and rituximab with peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.

Conditions

• Lymphoma

Interventions

BIOLOGICAL

filgrastim

5 ug/kg subQ daily day 4 until ANC \>10,000 (or ANC\> 5000 2X)Tx 1, 2, 4 10 ug/kg subQ daily day 14 until completion of PBSC collection Tx 3

BIOLOGICAL

rituximab

375 mg/sq m IV infusion at , or = 400 mg/hr day 1 Tx 1, 2, days 5 \& 12 Tx 3, and weekly for 2 doses Tx 5

DRUG

carmustine

15 mg/kg IV infusion over 2 hours Day 6, Tx 4

DRUG

cyclophosphamide

2000 mg/sq m IV infusion over 2 hours Day 3, Tx 1 \& 2 100 mg/kg IV infusion over 2 hours Day 2, Tx 4

DRUG

cytarabine

2000 mg/sq m IV infusion BID over 2 hours x 8 doses Days 1-4, Tx 3

DRUG

doxorubicin hydrochloride

50 mg/sq m IVP Day 3, Tx 1\& 2

DRUG

etoposide

40 mg/kg total dose continuous IV infusion over 96 hours Days 1-4, Tx 3

DRUG

leucovorin calcium

50 mg/sq m IV infusion q 6 hours x 3 doses after MTX, then 10 mg/sq m IV/PO q 6 hrs until MTX levels \<0.05 uM, Tx 1 \& 2

DRUG

methotrexate

300 mg/sq m IV infusion over 4 hrs Day 2 Tx 1 \& 2

DRUG

prednisone

100 mg/sq m PO Days 3-7, Tx 1 \& 2

DRUG

vincristine sulfate

1.4 mg/sq m IVP Day 3, Tx 1 \& 2

PROCEDURE

peripheral blood stem cell transplantation

Stem cells collected during Tx 3 will be transfused follwing chemotx in Tx 4

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• Lloyd Damon, MD · University of California, San Francisco

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-06-30

Primary Completion

2006-12-31

Completion

2009-09-30

Countries

• United States
• Puerto Rico

Study Locations