Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes



Status:Active, not recruiting
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 29
Updated:4/21/2016
Start Date:November 2004

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Treatment of Late Isolated Extramedullary Relapse From Acute Lymphoblastic Leukemia (ALL) (Initial CR1≥ 18 Months)

RATIONALE: Drugs used in chemotherapy work in 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. Giving combination chemotherapy together with radiation therapy may kill more
cancer cells.

PURPOSE: This clinical trial is studying how well giving chemotherapy together with
radiation therapy works in treating patients with acute lymphoblastic leukemia that has
relapsed in the CNS and/or testes.

OBJECTIVES:

Primary

- Determine the efficacy of intensified systemic chemotherapy with reduced-dose CNS
radiotherapy in patients with acute lymphoblastic leukemia and late isolated CNS
relapse.

- Determine the efficacy of intensive systemic chemotherapy without testicular
radiotherapy in patients with acute lymphoblastic leukemia and late isolated testicular
relapse.

- Determine the toxicity of these regimens in these patients.

Secondary

- Determine whether bone marrow involvement is present at the time of extramedullary
relapse in patients treated with these regimens.

- Correlate pretreatment minimal residual disease with outcomes in patients treated with
these regimens.

- Correlate the role of host gene polymorphisms with toxicity of these regimens and
incidence and outcome in these patients.

- Determine the neuropsychological sequelae associated with isolated CNS relapse and
these treatment regimens in these patients.

OUTLINE: This is a pilot, multicenter study. All patients receive common induction,
consolidation, re-induction, and intensification chemotherapy. Patients are stratified to
maintenance therapy according to site of extramedullary relapse (CNS vs testicular).

- Induction therapy (weeks 1-4): Patients receive vincristine IV on days 1, 8, 15, and
22; oral dexamethasone twice daily on days 1-28; daunorubicin* IV over 15 minutes on
days 1, 8, and 15; and intrathecal triple therapy** (ITT) comprising methotrexate,
hydrocortisone, and cytarabine on days 1, 8, 15, and 22.

NOTE: *The total dose of anthracyclines on this study is capped at 450 mg/m2. Once this dose
is reached, all subsequent doses of daunorubicin are omitted.

NOTE: **Patients with isolated testicular relapse receive ITT on day 1 only.

In addition to the above, patients with isolated testicular relapse also receive high-dose
methotrexate IV continuously over 24 hours on day -14. Patients with clinical signs of
disease at the end of induction undergo testicular biopsy.

Patients with CNS disease who do not achieve CNS remission after induction therapy receive
additional ITT as above on days 29 and 36.

- Consolidation therapy (weeks 5-10): Patients receive high-dose cytarabine IV over 3
hours twice daily on days 1-2 and 22-23 and pegaspargase intramuscularly (IM) on days 2
and 23. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on days
3 and 24 and continuing until blood counts recover.

Patients with isolated testicular relapse with positive biopsy results at the end of
induction undergo testicular radiotherapy once daily for a total of 12 fractions during
consolidation therapy.

- Intensification I (weeks 11-22): Patients receive high-dose methotrexate with
leucovorin calcium rescue IV over 24 hours on days 1, 22, 43, and 64 and oral
mercaptopurine once daily on days 2-6, 23-27, 44-48, and 65-69. Patients also receive
etoposide IV over 1 hour and cyclophosphamide IV over 15-30 minutes on days 8, 29, 50,
and 71. Patients receive ITT* on days 15, 36, 57, and 78.

NOTE: *Patients with isolated testicular relapse receive ITT on days 36 and 78 only.

- Reinduction therapy (weeks 23-26): Patients receive vincristine IV on days 1, 8, 15,
and 22; oral dexamethasone twice daily on days 1-7 and 15-21, and daunorubicin IV over
15 minutes on days 1, 8, and 15.

- Intensification II (weeks 27-50): Patients receive high-dose cytarabine IV over 3 hours
twice daily on days 1-2, 43-44, 85-86, and 127-128; pegaspargase IM on days 2, 44, 86,
and 128; ITT* on days 22, 64, 106, and 148; high-dose methotrexate IV continuously over
24 hours on days 29, 71, 113, and 155; oral mercaptopurine on days 30-34, 72-76,
114-118, and 156-160; and etoposide IV over 1 hour and cyclophosphamide IV over 15-30
minutes on days 36, 78, 120, and 162. Patients also receive G-CSF SC beginning on days
3, 45, 87, and 129 and continuing until blood counts recover.

NOTE: *Patients with isolated testicular relapse receive ITT on days 22 and 106 only.

- Chemotherapy and radiotherapy (weeks 51-54): Patients receive oral dexamethasone twice
daily on days 1-7 and 15-21, vincristine IV on days 1, 8, and 15, and pegaspargase IM
on days 1 and 15.

Patients with isolated CNS relapse also undergo cranial radiotherapy once daily, 5 days a
week, for a total of 12 fractions.

- Maintenance therapy for isolated CNS relapse: (weeks 55-104): Patients receive
dexamethasone PO orIV twice daily on days 1-5; oral mercaptopurine once daily on days
1-42; methotrexate IM on days 1, 8, 15, 22, 29, and 36; and vincristine IV and
cyclophosphamide IV over 1 hour on days 43, 50, 57, and 64. Treatment repeats every 10
weeks for 5 courses.

- Maintenance therapy for isolated testicular relapse:

- (Weeks 55-74): Patients receive ITT on day 1 and dexamethasone, mercaptopurine,
methotrexate, vincristine, and cyclophosphamide as in maintenance therapy for
isolated CNS relapse. Treatment repeats every 10 weeks for 2 courses.

- (Weeks 75-106): Patients receive vincristine IV on day 1; dexamethasone orally or
IV on days 1-5; oral mercaptopurine on days 1-28; and methotrexate IM on days 1,
8, 15, and 22. Treatment repeats every 28 days for 8 courses. Patients also
receive ITT on day 1 every 12 weeks for 3 doses.

Patients with combined testicular and CNS relapse receive high-dose methotrexate IV
continuously over 24 hours on day -14 in addition to the same chemotherapy and radiotherapy
administered during the induction, consolidation, intensification I, reinduction,
intensification II, and maintenance phases of therapy as isolated CNS relapse patients.

All patients undergo neuropsychological assessment within 3 months after completion of
induction therapy (before cranial radiotherapy) and at 2 years after completion of
treatment.

Patients are followed for survival.

DISEASE CHARACTERISTICS:

- Diagnosis of acute lymphoblastic leukemia (ALL)

- B-precursor lineage (T-precursor lineage closed to accrual as of 05/20/10)

- In first bone marrow remission (M1 by morphology) AND duration of first complete
remission ≥ 18 months from time of initial diagnosis

- First isolated CNS and/or testicular relapse

- Isolated CNS relapse, as defined by 1 of the following:

- WBC ≥ 5/mm^3 in cerebrospinal fluid (CSF) with blasts present on cytospin

- Any number of WBC in CSF with immunophenotypic proof of leukemic relapse,
defined by the following:

- Identifiable blasts AND 1 of the following:

- B-lineage (TdT OR CD-10-positive on 2 consecutive CSF samples
obtained 4 weeks apart)

- T-lineage (TdT AND CD-7 OR TdT positivity alone on 2 consecutive
CSF samples obtained 4 weeks apart) (Closed to accrual as of
05/20/10)

- Isolated testicular relapse, defined as biopsy proven testicular involvement

- No Down syndrome

- No T-cell ALL or T-cell non-Hodgkin lymphoma

- No known optic nerve and/or retinal involvement

PATIENT CHARACTERISTICS:

Age

- 18 months to 29 years at relapse

Performance status

- Karnofsky 30-100% (for patients > 16 years of age) OR

- Lansky 30-100% (for patients ≤ 16 years of age)

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Creatinine adjusted according to age as follows:

- No greater than 0.4 mg/dL (≤ 5 months)

- No greater than 0.5 mg/dL (6 months -11 months)

- No greater than 0.6 mg/dL (1 year-23 months)

- No greater than 0.8 mg/dL (2 years-5 years)

- No greater than 1.0 mg/dL (6 years-9 years)

- No greater than 1.2 mg/dL (10 years-12 years)

- No greater than 1.4 mg/dL (13 years and over [female])

- No greater than 1.5 mg/dL (13 years to 15 years [male])

- No greater than 1.7 mg/dL (16 years and over [male]) OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular

- Shortening fraction ≥ 27% by echocardiogram OR

- Ejection fraction ≥ 50% by MUGA

Other

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior bone marrow transplantation

Chemotherapy

- Prior total anthracycline dosage ≤ 360 mg/m^2

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- No prior systemic therapy for concurrent extramedullary relapse
We found this trial at
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Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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901 45th Street
West Palm Beach, Florida 33407
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Comprehensive Cancer Center Our newly expanded Comprehensive Cancer Center is the region’s...
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Youngstown, Ohio 44501
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Boise, ID
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121 Dekalb Ave
Brooklyn, New York 11205
(718) 250-8000
Brooklyn Hospital Center Welcome to The Brooklyn Hospital Center, dedicated to Keeping Brooklyn healthy and...
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3110 MacCorkle Ave. S.E.
Charleston, West Virginia 25304
304-347-1206
West Virginia University Health Sciences Center - Charleston The West Virginia University Robert C. Byrd...
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1801 West Taylor, Suite 1E
Chicago, Illinois 60612
312.355.1625
University of Illinois Cancer Center The University of Illinois Cancer Center is dedicated to reducing...
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1 Childrens Plaza
Dayton, Ohio 45404
(937) 641-3000
Dayton Children's - Dayton We have more than 290,000 reasons to make sure the care...
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4760 Sunset Blvd
Downey, California 90027
(323) 783-6151
Southern California Permanente Medical Group We
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820 4th Street North
Fargo, North Dakota 58122
(701) 234-6292
CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
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Grand Rapids, Michigan 49503
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Hershey, Pennsylvania 17033
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One Baylor Plaza
Houston, Texas 77030
(713) 798-4951
Baylor University Medical Center - Houston Baylor University Medical Center in Dallas began in 1903...
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