NCT00004228

Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma

Official Title:

Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma.

PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.

Eligibility

DISEASE CHARACTERISTICS:

* Newly diagnosed disseminated lymphoblastic lymphoma or localized lymphoblastic lymphoma\*

* Less than 25% tumor cells in the bone marrow
* Previously untreated (prior intrathecal cytarabine allowed if protocol therapy begins within 72 hours)
* Stage III or IV disease
* NOTE: \*Localized lymphoblastic lymphoma is closed to accrual as of 10/2005

PATIENT CHARACTERISTICS:

Age:

* 1 to 30

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Cardiovascular:

* Adequate cardiac function

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Emergency steroid therapy (if required) must be started within 72 hours prior to protocol therapy

Radiotherapy:

* Emergency radiotherapy (if required) must be started within 72 hours prior to protocol therapy

Surgery:

* Not specified

Other:

* No other prior therapy except for emergency treatment of airway obstruction and/or superior vena cava syndrome

Disease(s) and\or Condition(s)

Lymphoma

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: asparaginase
    • Description: Given IV
    • Arm Group Labels: A0 (localized disease Stg I/II) Modified CCG BFM, A1 (Disseminated, No CNS - CCG mod BFM w/out intens, A2 (Disseminated, No CNS - CCG mod BFM w/ intens, B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: DRUG
    • Name: cyclophosphamide
    • Description: Given IV
    • Arm Group Labels: A0 (localized disease Stg I/II) Modified CCG BFM, A1 (Disseminated, No CNS - CCG mod BFM w/out intens, A2 (Disseminated, No CNS - CCG mod BFM w/ intens, B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: DRUG
    • Name: cytarabine
    • Description: Given IV
    • Arm Group Labels: A0 (localized disease Stg I/II) Modified CCG BFM, A1 (Disseminated, No CNS - CCG mod BFM w/out intens, A2 (Disseminated, No CNS - CCG mod BFM w/ intens, B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: DRUG
    • Name: daunorubicin hydrochloride
    • Description: Given IV
    • Arm Group Labels: A0 (localized disease Stg I/II) Modified CCG BFM, A1 (Disseminated, No CNS - CCG mod BFM w/out intens, A2 (Disseminated, No CNS - CCG mod BFM w/ intens, B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: DRUG
    • Name: dexamethasone
    • Description: Given IV
    • Arm Group Labels: A0 (localized disease Stg I/II) Modified CCG BFM, A1 (Disseminated, No CNS - CCG mod BFM w/out intens, A2 (Disseminated, No CNS - CCG mod BFM w/ intens, B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: DRUG
    • Name: doxorubicin hydrochloride
    • Description: Given IV
    • Arm Group Labels: A0 (localized disease Stg I/II) Modified CCG BFM, A1 (Disseminated, No CNS - CCG mod BFM w/out intens, A2 (Disseminated, No CNS - CCG mod BFM w/ intens, B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: DRUG
    • Name: leucovorin calcium
    • Description: Given IV
    • Arm Group Labels: B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: DRUG
    • Name: mercaptopurine
    • Description: Given IV
    • Arm Group Labels: A0 (localized disease Stg I/II) Modified CCG BFM, A1 (Disseminated, No CNS - CCG mod BFM w/out intens, A2 (Disseminated, No CNS - CCG mod BFM w/ intens, B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: DRUG
    • Name: methotrexate
    • Description: Given IV
    • Arm Group Labels: A0 (localized disease Stg I/II) Modified CCG BFM, A1 (Disseminated, No CNS - CCG mod BFM w/out intens, A2 (Disseminated, No CNS - CCG mod BFM w/ intens, B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: DRUG
    • Name: prednisone
    • Description: Given IV
    • Arm Group Labels: A0 (localized disease Stg I/II) Modified CCG BFM, A1 (Disseminated, No CNS - CCG mod BFM w/out intens, A2 (Disseminated, No CNS - CCG mod BFM w/ intens, B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: DRUG
    • Name: thioguanine
    • Description: Given PO
    • Arm Group Labels: A0 (localized disease Stg I/II) Modified CCG BFM, A1 (Disseminated, No CNS - CCG mod BFM w/out intens, A2 (Disseminated, No CNS - CCG mod BFM w/ intens, B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: DRUG
    • Name: vincristine sulfate
    • Description: Given IV
    • Arm Group Labels: A0 (localized disease Stg I/II) Modified CCG BFM, A1 (Disseminated, No CNS - CCG mod BFM w/out intens, A2 (Disseminated, No CNS - CCG mod BFM w/ intens, B1 (Disseminated CNS- <Amend 7B) NHL/BFM-95 w/out intens, B1 (Disseminated CNS-) NHL/BFM-95 w/out intens, B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy, B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/intens
    • Type: RADIATION
    • Name: radiation therapy
    • Description:
    • Arm Group Labels: B2 (CNS+) NHL/BFM-95 w/intens delayed radiation therapy
Sponsor
  • Children's Oncology Group