NCT00003425

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation and amifostine in treating patients with cancer.

Trial Health

80
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_1 breast-cancer

Geographic Reach
1 country

4 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

December 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

February 20, 2004

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

4.6 years

First QC Date

November 1, 1999

Last Update Submit

April 25, 2013

Conditions

Breast CancerLeukemiaLymphomaNeuroblastomaOvarian CancerSarcomaUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomastage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage IIIB breast cancerrecurrent adult Hodgkin lymphomarefractory multiple myelomastage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerregional neuroblastomadisseminated neuroblastomastage 4S neuroblastomarecurrent neuroblastomastage III multiple myelomarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiaunspecified adult solid tumor, protocol specificuntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionovarian stromal cancerstage III ovarian germ cell tumorstage IV ovarian germ cell tumorrecurrent ovarian germ cell tumoracute undifferentiated leukemiastage III grade 1 follicular lymphomastage 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 1 follicular 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 lymphomastage IV adult Burkitt lymphomarecurrent grade 1 follicular 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 lymphomarecurrent adult Burkitt lymphomasecondary acute myeloid leukemiaborderline ovarian surface epithelial-stromal tumorovarian sarcomalocalized unresectable neuroblastomastage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomametastatic Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent 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 lymphoma

Study Arms (1)

Amifostine trihydrate

EXPERIMENTAL
Biological: filgrastimDrug: amifostine trihydrateDrug: cyclophosphamideDrug: melphalanProcedure: peripheral blood stem cell transplantation

Interventions

filgrastimBIOLOGICAL
Amifostine trihydrate
amifostine trihydrateDRUG
Also known as: WR-2721
Amifostine trihydrate
cyclophosphamideDRUG
Amifostine trihydrate
melphalanDRUG
Amifostine trihydrate
peripheral blood stem cell transplantationPROCEDURE
Amifostine trihydrate

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Confirmed diagnosis of primary tumor and/or recurrence that has a low curative potential using other therapies, including but not limited to: Acute leukemia Myeloma Breast cancer Ovarian cancer Hodgkin's disease Non-Hodgkin's lymphoma Neuroblastoma Ewing's sarcoma In the absence of recurrence, malignancies for which an autotransplant regimen is considered a reasonable therapeutic alternative are also considered Greater than 25% of bone marrow normal cellularity and less than 10% of volume composed of tumor cells No active brain metastases or carcinomatous meningitis (controlled CNS metastases eligible) PATIENT CHARACTERISTICS: Age: 14 to 70 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3000/mm3 Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin, SGOT, and SGPT less than 2 times normal Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF at least 45% Pulmonary: DLCO at least 50% FEV1 at least 60% Other: Not pregnant or nursing Fertile patients must use effective contraception HIV, HTLV-1, and HTLV-2 negative Hepatitis B and C negative PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior autologous peripheral blood stem cell transplant Chemotherapy: Cumulative anthracycline or equivalent dose no greater than 450 mg/m2 Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Recovered from prior therapy No antihypertensives during and 24 hours prior to amifostine administration

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

Sponsors & Collaborators

Study Sites (4)

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

  • Phillips GL, Meisenberg BR, Reece DE, Adams VR, Badros AZ, Brunner JL, Fenton RG, Filicko J, Grosso DL, Hale GA, Howard DS, Johnson VP, Kniska A, Marshall KW, Mookerjee B, Nath R, Rapoport AP, Sarkodee-Adoo C, Takebe N, Vesole DH, Wagner JL, Flomenberg N. Activity of single-agent melphalan 220-300 mg/m2 with amifostine cytoprotection and autologous hematopoietic stem cell support in non-Hodgkin and Hodgkin lymphoma. Bone Marrow Transplant. 2004 Apr;33(8):781-7. doi: 10.1038/sj.bmt.1704424.

    PMID: 14767498RESULT

  • Skliarova T, Lara-Cabrera ML, Hafstad H, Havnen A, Saether SG, Salvesen O, Vaag J, Torgersen T. Feasibility, acceptability and preliminary evaluation of a user co-facilitated psychoeducational programme: a feasibility proof-of-concept randomised control trial. BMC Psychiatry. 2024 Sep 16;24(1):615. doi: 10.1186/s12888-024-06015-4.

    PMID: 39285365DERIVED

MeSH Terms

Conditions

Breast NeoplasmsLeukemiaLymphomaNeuroblastomaOvarian NeoplasmsSarcomaHodgkin DiseaseMultiple MyelomaCarcinoma, Ovarian EpithelialLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Biphenotypic, AcuteLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-CellNeuroectodermal Tumors, Primitive, PeripheralLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

FilgrastimAmifostineCyclophosphamideMelphalanPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, Connective and Soft TissueNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersCarcinomaLeukemia, MyeloidLeukemia, LymphoidLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsOrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Donna E. Reece, MD

    Lucille P. Markey Cancer Center at University of Kentucky

    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

November 1, 1999

First Posted

February 20, 2004

Study Start

December 1, 1997

Primary Completion

July 1, 2002

Last Updated

April 26, 2013

Record last verified: 2013-04

Locations

US(4)