Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00002738

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

125

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as trimetrexate glucuronate and leucovorin, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating children with recurrent acute lymphoblastic leukemia, recurrent osteosarcoma, or refractory non-Hodgkin's lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma Sarcoma	Drug: leucovorin calcium Drug: trimetrexate glucuronate	Phase 2

Detailed Description

OBJECTIVES:

Determine the efficacy of trimetrexate glucuronate with leucovorin calcium rescue in children with recurrent acute lymphoblastic leukemia, recurrent osteogenic sarcoma, or refractory non-Hodgkin's lymphoma resistant to methotrexate.
Evaluate the toxicity of this treatment regimen in this patient population.

OUTLINE: Patients are stratified according to disease (acute lymphocytic leukemia, non-Hodgkin's lymphoma vs osteogenic sarcoma).

Patients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral leucovorin calcium every 12 hours on days 1-24. Treatment repeats every 4 weeks. Patients with stable or responsive disease may receive up to 4 courses of therapy.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Primary Purpose:

Treatment

Official Title:

Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia

Study Start Date :

Jan 1, 1996

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologic evidence of one of the following malignancies that has failed conventional therapy:
Acute lymphoblastic leukemia
Non-Hodgkin's lymphoma with bone marrow involvement
Osteogenic sarcoma
In vitro transport resistance to methotrexate demonstrated by bone marrow aspirate assay

PATIENT CHARACTERISTICS:

Age:

21 and under at diagnosis

Performance status:

ECOG 0-2

Life expectancy:

At least 8 weeks

Hematopoietic:

Granulocytopenia allowed with bone marrow involvement
Thrombocytopenia allowed with bone marrow involvement
Anemia allowed with bone marrow involvement

Hepatic:

(unless due to disease)
Bilirubin no greater than 2.0 mg/dL
AST no greater than 100

Renal:

Creatinine less than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

Other:

No other serious medical illness
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Prior bone marrow transplantation allowed

Chemotherapy:

At least 1 week since prior intrathecal treatment
At least 2 weeks since prior systemic chemotherapy and recovered
At least 10 days for rapidly proliferating leukemia (i.e., WBC greater than 50,000)
No concurrent chemotherapy