NCT00062140

Brief Summary

RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may decrease side effects while stopping cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_1 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

April 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

First QC Date

June 5, 2003

Last Update Submit

September 20, 2010

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases

Keywords

recurrent 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 cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomastage III adult lymphoblastic lymphomastage IV adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomarecurrent adult acute myeloid leukemiauntreated adult acute myeloid leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiarelapsing chronic myelogenous leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesnoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomarecurrent mycosis fungoides/Sezary syndromesecondary acute myeloid leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III grade 3 follicular lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult immunoblastic large cell lymphomastage III mantle cell lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult immunoblastic large cell lymphomastage IV mantle cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomarecurrent adult acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiaatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiablenoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone 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)

Interventions

cyclophosphamideDRUG
allogeneic bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of hematological malignancy, including any of the following: * Chronic myeloid leukemia * Acute myeloid leukemia * Acute lymphocytic leukemia * Myelodysplastic syndromes * Lymphoma * Unlikely to respond to conventional treatment and would benefit from hematopoietic stem cell transplantation * No bulky tumor mass requiring additional involved field radiotherapy * No large body burden of tumor cells requiring cytoreductive chemotherapy before total body irraditation and cyclophosphamide * Undergoing conditioning for transplantation at the University of Washington Medical Center * Availability of 1 of the following types of allogeneic donors: * HLA-identical family members * Unrelated donors * Allele match (match grade 1) * One allele mismatch for A, B, C, DRB1 or DQB1 (match grades 2.1 or 2.2) PATIENT CHARACTERISTICS: Age * 18 to 65 Performance status * Not specified Life expectancy * Not severely limited by diseases other than malignancy * Not moribund Hematopoietic * Not specified Hepatic * Bilirubin no greater than 1.2 mg/dL * No cirrhosis * No hepatic fibrosis with bridging Renal * Creatinine no greater than 1.2 mg/dL Cardiovascular * No coronary artery disease * No congestive heart failure requiring therapy Pulmonary * Oxygen saturation at least 93% (on room air) Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No concurrent infection requiring systemic antibiotic or antifungal therapy PRIOR CONCURRENT THERAPY: Biologic therapy * No prior hematopoietic stem cell transplantation Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior radiotherapy to the liver or adjacent organs Surgery * Not specified Other * No concurrent aspirin or nonsteroidal anti-inflammatory medications such as ibuprofen (e.g., Motrin® or Advil®) * No other concurrent phase I study enrollment

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

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Myeloid, AcuteLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myeloid, Chronic-PhaseMycosis FungoidesSezary SyndromeLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellCongenital Abnormalities

Interventions

CyclophosphamidePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLymphoma, T-CellLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, B-CellCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • George B. McDonald, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

April 1, 2003

Study Completion

July 1, 2004

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(1)