NCT00005092

Brief Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Transplanting donated cells that have been treated with psoralen may prevent this from happening. PURPOSE: Phase I trial to study the effectiveness of chemotherapy, radiation therapy, and psoralen-treated donor cells in treating patients who are undergoing peripheral stem cell transplantation for hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1 leukemia

Timeline
Completed

Started May 1999

Geographic Reach
1 country

3 active sites

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

May 28, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2002

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

April 23, 2004

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

3.3 years

First QC Date

April 6, 2000

Last Update Submit

October 24, 2018

Conditions

LeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent childhood acute lymphoblastic leukemiarecurrent adult Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarefractory multiple myelomastage III multiple myelomastage III childhood lymphoblastic lymphomastage IV childhood lymphoblastic lymphomarecurrent childhood lymphoblastic lymphomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiachildhood diffuse large cell lymphomachildhood immunoblastic large cell lymphomachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiameningeal chronic myelogenous leukemiaadult acute monoblastic leukemia and acute monocytic leukemia (M5)childhood acute monoblastic leukemia and acute monocytic leukemia (M5)T-cell large granular lymphocyte leukemiaB-cell chronic lymphocytic leukemiaPhiladelphia chromosome positive chronic myelogenous leukemiaPhiladelphia chromosome negative chronic myelogenous leukemiaL1 childhood acute lymphoblastic leukemiaL2 childhood acute lymphoblastic leukemiaL3 childhood acute lymphoblastic leukemiaT-cell childhood acute lymphoblastic leukemiaB-cell childhood acute lymphoblastic leukemianon-T, non-B childhood acute lymphoblastic leukemianon-T, non-B, cALLa positive childhood acute lymphoblastic leukemianon-T, non-B, cALLa negative childhood acute lymphoblastic leukemianon-T, non-B, cALLa positive, pre-B childhood acute lymphoblastic leukemiaL1 adult acute lymphoblastic leukemiaL2 adult acute lymphoblastic leukemiaL3 adult acute lymphoblastic leukemiaT-cell adult acute lymphoblastic leukemiaB-cell adult acute lymphoblastic leukemianon-T, non-B adult acute lymphoblastic leukemianon-T, non-B, cALLa positive adult acute lymphoblastic leukemianon-T, non-B, cALLa positive, pre-B adult acute lymphoblastic leukemianon-T, non-B, cALLa negative adult acute lymphoblastic leukemiaTdT positive adult acute lymphoblastic leukemiaTdT negative adult acute lymphoblastic leukemiaTdT negative childhood acute lymphoblastic leukemiaTdT positive childhood acute lymphoblastic leukemiaadult acute erythroid leukemia (M6)adult acute myeloblastic leukemia without maturation (M1)adult acute myeloblastic leukemia with maturation (M2)adult acute promyelocytic leukemia (M3)adult acute myelomonocytic leukemia (M4)adult acute monoblastic leukemia (M5a)adult acute eosinophilic leukemiaadult acute basophilic leukemiaadult acute megakaryoblastic leukemia (M7)childhood acute myeloblastic leukemia without maturation (M1)childhood acute myeloblastic leukemia with maturation (M2)childhood acute promyelocytic leukemia (M3)childhood acute myelomonocytic leukemia (M4)childhood acute monoblastic leukemia (M5a)childhood acute monocytic leukemia (M5b)childhood acute erythroleukemia (M6)childhood acute eosinophilic leukemiachildhood acute basophilic leukemiachildhood acute megakaryocytic leukemia (M7)untreated hairy cell leukemiachronic myelomonocytic leukemiaacute undifferentiated leukemiastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III adult Burkitt lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomarecurrent adult T-cell leukemia/lymphomasecondary acute myeloid leukemiade novo myelodysplastic syndromesadult acute monocytic leukemia (M5b)previously treated myelodysplastic syndromessecondary myelodysplastic syndromesprolymphocytic leukemiaadult acute minimally differentiated myeloid leukemia (M0)childhood acute minimally differentiated myeloid leukemia (M0)intraocular lymphomastage III childhood large cell lymphomastage IV childhood large cell lymphomarecurrent childhood large cell lymphomachildhood large cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomaangioimmunoblastic T-cell lymphomaanaplastic large cell lymphomastage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromerecurrent mycosis fungoides/Sezary syndromechildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of T-cells photochemically treated with psoralen and ultraviolet A

    MTD defined as dose preceding that at which at least 2 of 3 patients experience dose limiting toxicities. Patients followed for 100 days.

    100 days

Study Arms (1)

Chemo, RT + PSCT

EXPERIMENTAL

Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation

Drug: CyclophosphamideDrug: PsoralenDrug: ThiotepaProcedure: Allogeneic bone marrow transplantationProcedure: In vitro-treated peripheral blood stem cell transplantation (PBSCT)Radiation: Radiation Therapy (RT)

Interventions

CyclophosphamideDRUG

IV over 2 hours on days 2 and 3

Also known as: Cytoxan, Neosar
Chemo, RT + PSCT
PsoralenDRUG

Psoralen treated T-cell allogeneic transplant on day 9

Also known as: Methoxsalen, 8-methoxypsoralen, UVADEX, Oxsoralen-Ultra, Oxsoralen, 8-MOP
Chemo, RT + PSCT
ThiotepaDRUG

IV over 2 hours on day 1

Chemo, RT + PSCT
Allogeneic bone marrow transplantationPROCEDURE

Preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9

Chemo, RT + PSCT
In vitro-treated peripheral blood stem cell transplantation (PBSCT)PROCEDURE

Preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9

Also known as: PBSCT
Chemo, RT + PSCT
Radiation Therapy (RT)RADIATION

Whole body radiotherapy on days 5-8.

Also known as: Radiotherapy
Chemo, RT + PSCT

Eligibility Criteria

AgeUp to 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: Hematologic malignancy, including acute myeloid or lymphoid leukemia of any FAB subtype, not in remission with chemotherapy or requiring bone marrow transplant OR Chronic myeloid leukemia, advanced beyond first chronic phase OR Myelodysplasia, including secondary to prior chemotherapy, with: Granulocyte count less than 500/mm3 OR Platelet count less than 50,000/mm3 OR High risk cytogenetic abnormalities such as +8, -7, -5, or 11q23 OR Intermediate or high grade lymphoma without response to initial therapy or in relapse OR Multiple myeloma without response to initial therapy or in relapse OR Stage IV low grade lymphoma or chronic lymphocytic leukemia not achieving remission with 2 regimens No aplastic anemia Related haploidentical donor (1-3 HLA-A, B, and/or DR mismatch) for collection of stem cells and whole blood T-cells required PATIENT CHARACTERISTICS: Age: 6 months to 49 years Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.5 mg/dL SGPT less than 3 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction at least 45% No symptoms or active treatment of left ventricular failure Pulmonary: Corrected DLCO at least 50% Other: No acute viral, bacterial, or fungal infection No prior transfusion associated graft versus host disease No other medical condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy or interferon alfa and recovered No prior autologous or allogeneic progenitor cell transplant Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered 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 (3)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Washington University Barnard Cancer Center

St Louis, Missouri, 63110, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesHodgkin DiseasePrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, T-Cell, CutaneousLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcuteLymphoma, Large B-Cell, DiffuseLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Monocytic, AcuteLeukemia, Large Granular LymphocyticLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Erythroblastic, AcuteLeukemia, Promyelocytic, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Eosinophilic, AcuteLeukemia, Basophilic, AcuteLeukemia, Megakaryoblastic, AcuteLeukemia, Myelomonocytic, ChronicLeukemia, Biphenotypic, AcuteLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, ProlymphocyticIntraocular LymphomaDendritic Cell Sarcoma, InterdigitatingLymphoma, Mantle-CellImmunoblastic LymphadenopathyLymphoma, Large-Cell, AnaplasticMycosis FungoidesSezary Syndrome

Interventions

CyclophosphamideFicusinMethoxsalenThiotepaRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBone Marrow DiseasesLeukemia, LymphoidLymphoma, T-CellLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidLymphoma, B-CellMyeloproliferative DisordersCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, T-CellMyelodysplastic-Myeloproliferative DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsEye NeoplasmsNeoplasms by SiteHistiocytic Disorders, MalignantHistiocytosisLymphadenopathy

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsFurocoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingTriethylenephosphoramideAziridinesAzirinesTherapeutics

Study Officials

  • James Gajewski, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2000

First Posted

April 23, 2004

Study Start

May 28, 1999

Primary Completion

August 28, 2002

Study Completion

August 28, 2002

Last Updated

October 26, 2018

Record last verified: 2018-10

Locations

US(3)