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

Primary Purpose

Leukemia, Lymphoma, Sarcoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
leucovorin calcium
trimetrexate glucuronate
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood acute lymphoblastic leukemia, recurrent childhood lymphoblastic lymphoma, recurrent osteosarcoma, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept 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 Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed and recovered No concurrent radiotherapy Surgery: Not specified

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 6, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002738
Brief Title
Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma
Official Title
Phase II Trial of Trimetrexate and Leucovorin in The Treatment of Recurrent Childhood Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Sarcoma
Keywords
recurrent childhood acute lymphoblastic leukemia, recurrent childhood lymphoblastic lymphoma, recurrent osteosarcoma, recurrent childhood small noncleaved cell lymphoma, recurrent childhood large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
trimetrexate glucuronate

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed and recovered No concurrent radiotherapy Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya Trippett, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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