NCT00003269

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of amifostine followed by high-dose chemotherapy in treating patients with hematologic cancer or solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Feb 1998

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

February 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

May 24, 2004

Completed
Last Updated

January 10, 2011

Status Verified

January 1, 2011

Enrollment Period

2.9 years

First QC Date

November 1, 1999

Last Update Submit

January 6, 2011

Conditions

Breast CancerDrug/Agent Toxicity by Tissue/OrganLung CancerLymphomaOvarian CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomastage I breast cancerstage II breast cancerstage IV breast cancerstage IIIA breast cancerstage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIB breast cancerstage I cutaneous T-cell non-Hodgkin lymphomastage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomastage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerWaldenstrom macroglobulinemialimited stage small cell lung cancerextensive stage small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerunspecified adult solid tumor, protocol specificstage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I adult diffuse small cleaved cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult immunoblastic large cell lymphomastage I adult lymphoblastic lymphomastage I adult Burkitt lymphomastage 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 lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomadrug/agent toxicity by tissue/organstage I mantle cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II mantle cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult Burkitt lymphomacontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult lymphoblastic lymphomastage III mantle cell lymphomastage IV mantle cell lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomastage I marginal zone lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

  • duration of neutropenia

    number of days absolute neutrophil count less than 500 during the nadir period after administration of high dose chemotherapy

    30 days

Secondary Outcomes (2)

  • incidence of nephrotoxicity

    30 days

  • incidence of ototoxicity

    30 days

Interventions

sargramostimBIOLOGICAL
amifostine trihydrateDRUG
cisplatinDRUG
cyclophosphamideDRUG
etoposideDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed hematologic malignancies and adult solid tumors, including: Non-Hodgkin's lymphoma Lung cancer Hodgkin's disease Ovarian cancer Breast cancer No refractory disease (less than partial response to induction chemotherapy) No CNS metastases No unilateral bone marrow biopsy within 6 months of study showing at least 20% involvement by fibrosis tumors Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 to 70 Menopausal status: Not specified Performance Status: ECOG 0-2 Life expectancy: At least 16 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No underlying medical or psychiatric conditions No concurrent active infection No prior malignancies except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior myeloid growth factor Chemotherapy: At least 4 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen (excluding adjuvant chemotherapy) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since pelvic, para-aortic, inverted Y, cranial, spinal, or mediastinal radiation Surgery: At least 2 weeks since major surgery Other: No antihypertensive medication within 24 hours of 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 (1)

Scripps Clinic

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsDrug-Related Side Effects and Adverse ReactionsLung NeoplasmsLymphomaOvarian NeoplasmsHodgkin DiseaseCarcinoma, Non-Small-Cell LungLymphoma, T-Cell, CutaneousCarcinoma, Ovarian EpithelialWaldenstrom MacroglobulinemiaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

sargramostimAmifostineCisplatinCyclophosphamideEtoposide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesChemically-Induced DisordersRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinoma, BronchogenicBronchial NeoplasmsLymphoma, T-CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLymphoma, B-CellLeukemia, LymphoidLeukemiaEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Study Officials

  • James R. Mason, MD

    Ida M. and Cecil H. Green Cancer Center at Scripps Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 24, 2004

Study Start

February 1, 1998

Primary Completion

January 1, 2001

Study Completion

January 1, 2001

Last Updated

January 10, 2011

Record last verified: 2011-01

Locations

US(1)