NCT00002738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_2 leukemia

Timeline
Completed

Started Jan 1996

Longer than P75 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

10.4 years

First QC Date

November 1, 1999

Last Update Submit

March 6, 2013

Conditions

LeukemiaLymphomaSarcoma

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent childhood lymphoblastic lymphomarecurrent osteosarcomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphoma

Interventions

leucovorin calciumDRUG
trimetrexate glucuronateDRUG

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaSarcomaPrecursor Cell Lymphoblastic Leukemia-LymphomaOsteosarcomaBurkitt LymphomaDendritic Cell Sarcoma, Interdigitating

Interventions

Leucovorintrimetrexate glucuronate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Connective and Soft TissueLeukemia, LymphoidNeoplasms, Bone TissueNeoplasms, Connective TissueEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

FormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and Coenzymes

Study Officials

  • Tanya Trippett, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

January 1, 1996

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

US(1)