MDACC Study Summary COGAALL02P2 (Archived)

Study Summary
No. COGAALL02P2:.......Leukemia; Pediatrics......Anna Franklin......Pediatrics

Study Summary Title



Study Summary Number:	COGAALL02P2

Study Title:	Treatment of Late Isolated Extramedullary Relapse from Acute Lymphoblastic Leukemia (ALL) (Initial CR1 >/= 18 months)

Physician

New Patient Referral



Name:	Anna Franklin	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6620 Contact us about clinical trials

General Information



Disease Group:	Leukemia Pediatrics	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	For follow-up visits: a) q 4-8 wks during 1st year post therapy b) q 2 mos during 2nd year off-treatment c) q 3 mos during 3rd year off-treatment d) q 6 mos during 4th year off-treatment e) q 6-12 mos during 5th year off-treatment

Treatment Agents:	6-MP Cyclophosphamide Cytarabine Daunorubicin Dexamethasone Etoposide G-CSF Hydrocortisone Leucovorin Mesna Methotrexate Pegfilgrastim PEG-L-Asparaginase Vincristine Sulfate	Home Care:	During certain phases, Dexamethasone, Mercaptopurine, Methotrexate, and Leucovorin may be given at home.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Inpatient admission will be appropriate for patients receiving high dose chemotherapy. Additional hospitalizations will be necessary during periods of febrile neutropenia, fever, and possibly for other illnesses.


Description/ Intervention:	The goal of this clinical research study is to learn if more intense chemotherapy (anti-cancer drugs) than normal used with less radiation therapy than normal can help to control ALL, without causing the same level of long-term side effects seen in standard radiation therapy. The safety of this treatment combination will also be studied.

Study Objectives / Outcomes

Primary Objectives

The primary goal of this trial is to determine the efficacy and toxicity of intensified systemic chemotherapy with REDUCED CNS XRT (1200 cGy cranial) for children with ALL and isolated CNS relapse occurring more than 18 months after initial diagnosis (late isolated CNS relapse).

And to determine efficacy and toxicity of intensive systemic chemotherapy WITHOUT testicular XRT for patients with late isolated testicular relapse (ITR).

Secondary Objectives

The secondary goal of this trial is to determine if bone marrow (BM) involvement is present at the time of extramedullary (EM) relapse of ALL, and to assess if pre-treatment MRD correlates with outcomes of patients with isolated CNS and testicular relapse.

to determine the role of host gene polymorphisms in the incidence, outcome and toxicity of patients with extramedullary relapse of ALL,

to determine the neuropsychological sequelae associated with isolated CNS relapse of ALL and its treatment.

Study Status Information



Study Activation / Registration Date:	05/10/2007

IRB Review and Approval Date:	05/10/2007

Study Type:	Other

Recruitment Status:	Terminated

Projected Accrual:	198

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient must be >/= 18 months and < 30 years of age at time of relapse.

2) Diagnosis of ALL (either B-precursor or T-Lineage) in first BM remission with first isolated CNS and/or testicular relapse.or diagnosis of Lymphoblastic NHL with first isolated CNS and/or testicular relapse.(see Section 3.3 for definitions of CNS and Testicular Relapse). Length of initial complete remission must be >/= 18 months from the time of initial diagnosis. Bone marrow must be M1 by morphology.

3) Performance score of >/=30. Use Karnofsky for patients > 16 years of age and Lansky for patients </= 16 years of age.

4) Patient should not have had prior (non-protocol specified) systemic therapy for current extramedullary relapse. IT therapy given within one week of beginning systemic Induction will be considered Day 1 dose of ITT and total anthracycline dosage must be </= 360 mg/m^2.

5) Creatinine clearance or radioisotope GFR >/= 70ml/min/1.73m^2 Or A serum creatinine based on age/gender as follows: 1 mo to < 6 mos max. serum creat of 0.4 for male and female, 6 mos to < 1 yr max. serum creat of 0.5 for male and female, 1 to < 2yrs max. serum creat of 0.6 for male and female, 2 to <6 yrs max. serum creat of 0.8 for male and female, 6 to <10 yrs max. serum creat of 1 for male and female, 10 to < 13 yrs max. serum creat 1.2 for male and female, 13 to < 16 yrs max. serum creat of 1.5 for male and 1.4 for female, >/= 16 yrs max. serum creat of 1.7 for male and 1.4 for female.

6) Adequate cardiac function defined as: - Shortening fraction of >/= 27% by echocardiogram, or - Ejection fraction of >= 50% by radionuclide angiogram (MUGA).

7) All patients and/or a parent or legal guardian must sign a written informed consent. And all institutional, FDA, and NCI requirements for human studies must be met.

Exclusion Criteria:

1) Patients with Down's syndrome are not eligible due to increased sensitivity to MTX.

2) Patients who have had a BMT in first remission are not eligible.

3) Patients with known optic nerve and or retinal involvement are not eligible (because they are unable to delay XRT for 12 months). Patients presenting with visual disturbances should have an opthalmological exam and, if indicated, an MRI to determine optic nerve or retinal involvement.

Links

Registration Number: NCT00096135
Study Information on Clinical Trials Registry (clinicaltrials.gov)