Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Summary

This pilot, phase II trial studies the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving bortezomib together with combination chemotherapy may kill more cancer cells.

Conditions

• B-cell Adult Acute Lymphoblastic Leukemia
• B-cell Childhood Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Adult Lymphoblastic Lymphoma
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Recurrent Childhood Lymphoblastic Lymphoma
• T-cell Adult Acute Lymphoblastic Leukemia
• T-cell Childhood Acute Lymphoblastic Leukemia

Interventions

DRUG

L-asparaginase

Given IM 6000 IU/m2/dose Days 2 and 9

DRUG

doxorubicin hydrochloride

Given IV 60 mg/m2/dose on Day 1

DRUG

therapeutic hydrocortisone

Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22

DRUG

vincristine sulfate

Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22

DRUG

cytarabine

Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9

DRUG

prednisone

Given PO or IV 40 mg/m2/day on Days 1-28

DRUG

bortezomib

Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8

DRUG

pegaspargase

Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22

DRUG

methotrexate

Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22

DRUG

etoposide phosphate

Given IV 100 mg/m2/dose on Days 1-5

DRUG

cyclophosphamide

Given IV 440 mg/m2/dose on Days 1-5

BIOLOGICAL

filgrastim

Given IV or SC 5 micrograms/kg/dose Only on Day 6

DRUG

leucovorin calcium

Given PO or IV 15mg/m2/dose q6h x 3 doses

OTHER

laboratory biomarker analysis

Correlative studies

DRUG

High Dose MTX

IV 5000 mg/m2/dose Block 2: Day 22

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Terzah Horton, MD PhD · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

31 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2014-09-30

Completion

2014-09-30

Countries

• United States
• Australia
• Canada
• Puerto Rico

Study Locations