NCT00004898

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy and chemotherapy plus peripheral stem cell transplantation in treating patients who have high-grade lymphoma or acute lymphoblastic leukemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started Oct 1999

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

October 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 3, 2004

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

3.8 years

First QC Date

March 7, 2000

Last Update Submit

June 8, 2012

Conditions

LeukemiaLymphoma

Keywords

recurrent childhood acute lymphoblastic leukemiastage I childhood lymphoblastic lymphomastage II childhood lymphoblastic lymphomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood lymphoblastic lymphomarecurrent adult acute lymphoblastic leukemiaadult acute lymphoblastic leukemia in remissionchildhood acute lymphoblastic leukemia in remissionstage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I adult Burkitt lymphomastage II adult immunoblastic large cell lymphomastage II adult lymphoblastic lymphomastage II adult Burkitt lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV adult Burkitt lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomastage I childhood small noncleaved cell lymphomastage I childhood large cell lymphomastage II childhood small noncleaved cell lymphomastage II childhood large cell lymphomastage III childhood small noncleaved cell lymphomastage III childhood large cell lymphomastage IV childhood small noncleaved cell lymphomastage IV childhood large cell lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphoma

Interventions

filgrastimBIOLOGICAL
cyclophosphamideDRUG
etoposideDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven high grade lymphoma (including small noncleaved) by lymph node biopsy OR acute lymphoblastic leukemia (ALL) by bone marrow aspiration and biopsy Lymphoblastic lymphoma: First remission allowed if elevated LDH or stage IV disease Early relapse allowed Must have CT of abdomen, pelvis, and chest obtained within 4-6 weeks prior to enrollment Measurable disease not required First remission transplantation is encouraged if poor prognostic indicators were present at diagnosis and the objective parameter of measure is long term disease free survival ALL: Patients with inaspirable bone marrow aspirate smears eligible if diagnosis confirmed by bone marrow core biopsy Any complete remission allowed All patients in relapse should have attempted reinduction of remission Patients in early relapse (defined as no greater than 20% lymphoblasts in bone marrow) eligible if bone marrow harvested while in remission (less than 5% blasts) Must be eligible for total body irradiation Negative CSF cytology within 4-6 weeks of enrollment No active CNS lymphoma or leukemia A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: Physiologic age 65 and under for autologous peripheral blood stem cell transplantation If age 55 and under, priority should be given to finding an allogeneic donor Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT less than 2 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction at least 40% by MUGA scan or clearance by a cardiologist No myocardial infarction within the past 6 months No active angina pectoris Pulmonary: FEV1 and DLCO at least 50% predicted Other: No active serious psychiatric or medical illness that would preclude administration of high dose chemotherapy HIV negative Not pregnant Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy greater than 25 Gy to the craniospinal axis Surgery: See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaDendritic Cell Sarcoma, Interdigitating

Interventions

FilgrastimCyclophosphamideEtoposidePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLymphoma, Non-HodgkinEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellHistiocytic Disorders, MalignantHistiocytosis

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Ann Traynor, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2000

First Posted

March 3, 2004

Study Start

October 1, 1999

Primary Completion

July 1, 2003

Study Completion

July 1, 2003

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

US(1)