NCT00047021

Brief Summary

RATIONALE: Drugs used in chemotherapy 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: Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_2 leukemia

Timeline
Completed

Started Nov 2001

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

November 1, 2001

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

June 11, 2010

Status Verified

June 1, 2010

Enrollment Period

3.8 years

First QC Date

October 3, 2002

Last Update Submit

June 10, 2010

Conditions

LeukemiaLymphoma

Keywords

accelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarecurrent childhood large cell lymphomarecurrent childhood lymphoblastic lymphomarecurrent childhood small noncleaved cell lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent/refractory childhood Hodgkin lymphomarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiachildhood chronic myelogenous leukemiaatypical chronic myeloid leukemiarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomaadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)

Outcome Measures

Primary Outcomes (1)

  • Event free survival at day 14 (myeloid engraftment)

    day 14

Secondary Outcomes (1)

  • Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment

    followed for 3 months

Interventions

sargramostimBIOLOGICAL

Sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.

cytarabineDRUG

high-dose cytarabine IV over 1 hour on days 1-5

mitoxantrone hydrochlorideDRUG

high-dose mitoxantrone IV over 15-30 minutes on day 5.

Eligibility Criteria

AgeUp to 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * One of the following must be present: * Histologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia * More than 5% blasts in the bone marrow or peripheral blood unrelated to recovery of normal hematopoiesis from prior chemotherapy * Failed at least 1 attempt at induction chemotherapy * Diagnosis of non-Hodgkin's lymphoma or Hodgkin's lymphoma * Refractory or relapsed after at least 1 regimen of standard chemotherapy * Diagnosis of chronic myelogenous leukemia in accelerated phase or blast crisis * Received at least 1 myelotoxic chemotherapy regimen * Active CNS involvement allowed PATIENT CHARACTERISTICS: Age * 55 and under Performance status * ECOG 0-2 Life expectancy * At least 5 weeks Hematopoietic * Lymphoma patients: * WBC at least 2,000/mm\^3\* * Platelet count at least 20,000/mm\^3\* NOTE: \*Unless due to bone marrow involvement or disease process Hepatic * Bilirubin no greater than 3 times normal\* * AST/ALT no greater than 3 times normal\* * Alkaline phosphatase no greater than 3 times normal\* * No severe liver failure NOTE: \*Unless related to leukemia Renal * Creatinine clearance greater than 50 mL/min * No severe renal failure Cardiovascular * LVEF at least 45% by MUGA Pulmonary * DLCO at least 60% of predicted Other * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No psychiatric illness that would preclude informed consent * No medical illness or other condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * At least 24 hours since prior hydroxyurea * At least 1 week since other prior chemotherapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Recovered from prior therapy

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

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-7284, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Myeloid, Accelerated PhaseBlast CrisisPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticDendritic Cell Sarcoma, InterdigitatingLymphoma, FollicularLymphoma, Mantle-CellRecurrenceLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellCongenital Abnormalities

Interventions

sargramostimCytarabineMitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, LymphoidLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisMyelodysplastic-Myeloproliferative DiseasesLeukemia, B-CellCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic Compounds

Study Officials

  • Mary J. Laughlin, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2002

First Posted

January 27, 2003

Study Start

November 1, 2001

Primary Completion

August 1, 2005

Study Completion

September 1, 2005

Last Updated

June 11, 2010

Record last verified: 2010-06

Locations

US(1)