NCT00006368

Brief Summary

RATIONALE: Radiolabeled drugs such as yttrium Y 90 SMT 487 can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 SMT 487 in treating patients who have refractory or recurrent cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 1998

Longer than P75 for phase_1

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

January 1, 1998

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 2, 2004

Completed
Last Updated

May 1, 2013

Status Verified

April 1, 2013

Enrollment Period

5.8 years

First QC Date

October 4, 2000

Last Update Submit

April 30, 2013

Conditions

Brain and Central Nervous System TumorsBreast CancerGastrointestinal Carcinoid TumorIslet Cell TumorLung CancerLymphomaMelanoma (Skin)Neoplastic Syndrome

Keywords

stage IV adult Hodgkin lymphomastage IV breast cancerrecurrent breast cancerrecurrent non-small cell lung cancerrecurrent adult Hodgkin lymphomaextensive stage small cell lung cancerrecurrent small cell lung cancermetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorgastrinomarecurrent adult brain tumorinsulinomarecurrent islet cell carcinomaACTH-producing pituitary tumorprolactin-producing pituitary tumorgrowth hormone-producing pituitary tumorrecurrent pituitary tumorTSH producing pituitary tumornonfunctioning pituitary tumoradult brain stem gliomaadult craniopharyngiomaadult medulloblastomaadult meningiomaadult glioblastomastage IV melanomarecurrent melanomastage IV non-small cell lung cancerWDHA syndromesomatostatinomapancreatic polypeptide tumorglucagonomapulmonary carcinoid tumorstage 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 lymphomaadult anaplastic astrocytomaadult myxopapillary ependymomaadult anaplastic ependymomaadult anaplastic oligodendrogliomaadult central nervous system germ cell tumoradult pilocytic astrocytomaadult subependymomaadult ependymoblastomaadult pineocytomaadult pineoblastomaadult meningeal hemangiopericytomastage IV mantle cell lymphomarecurrent mantle cell lymphomaadult choroid plexus tumorrecurrent marginal zone lymphomarecurrent small lymphocytic 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 grade III meningiomaadult giant cell glioblastomaadult gliosarcoma

Interventions

yttrium Y 90-edotreotideRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed, progressive malignant neoplasm Clinical diagnosis of multiple endocrine neoplasia (MEN) types I and II allowed Tumors positive for somatostatin receptors by octreotide scintigraphy, such as: Pituitary Brain Endocrine pancreatic Lymphoma Carcinoid Melanoma Small cell lung Breast Disease not amenable to standard treatment OR Failed existing first and second line therapies (failed at least 1 regimen in the case of small cell lung cancer) Bone disease (no diffuse bone marrow involvement), pleural effusions, and ascites allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Course I: Karnofsky 50-100% Courses II-IV: Karnofsky 30-100% Life expectancy: At least 6 months and no greater than 2.5 years (for course I only) Hematopoietic: Course I: Hemoglobin at least 8 g/dL WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Courses II-IV: WBC at least 3,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 1.7 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No history of congestive heart failure unless ejection fraction at least 40% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No other concurrent malignancy except MEN I or II or squamous cell skin cancer No concurrent significant, uncontrolled, medical, psychiatric, or surgical condition that would preclude study (course 1) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy Greater than 4 weeks since prior chemotherapy Endocrine therapy: At least 4 months since prior long acting somatostatin analogue Concurrent hormonal therapy (except somatostatin analogues) allowed if started at least 2 months previously Radiotherapy: Greater than 4 weeks since prior radiotherapy No prior radiotherapy to at least 25% of bone marrow Surgery: Greater than 4 weeks since prior surgery Other: Greater than 4 weeks since prior investigational drugs No other concurrent investigational drug therapy No other concurrent antineoplastic therapy Concurrent bisphosphonates allowed

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

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsBreast NeoplasmsAdenoma, Islet CellLung NeoplasmsLymphomaMelanomaNeoplasmsHodgkin DiseaseCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaGastrinomaBrain NeoplasmsInsulinomaCarcinoma, Islet CellGrowth Hormone-Secreting Pituitary AdenomaPituitary NeoplasmsCraniopharyngiomaMedulloblastomaMeningiomaGlioblastomaVipomaSomatostatinomaGlucagonomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaAstrocytomaEpendymomaOligodendrogliomaGlioma, SubependymalNeuroectodermal Tumors, PrimitivePinealomaLymphoma, Mantle-CellChoroid Plexus NeoplasmsLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellGliosarcoma

Interventions

90Y-octreotide, DOTA-Tyr(3)-

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNervous System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePancreatic NeoplasmsDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaBrain DiseasesCentral Nervous System DiseasesPituitary DiseasesHypothalamic DiseasesHypothalamic NeoplasmsSupratentorial NeoplasmsGliomaNeoplasms, NeuroepithelialNeoplasms, Vascular TissueMeningeal NeoplasmsCarcinoma, NeuroendocrineLymphoma, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsCerebral Ventricle NeoplasmsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Larry K. Kvols, MD

    H. Lee Moffitt Cancer Center and Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2000

First Posted

April 2, 2004

Study Start

January 1, 1998

Primary Completion

November 1, 2003

Study Completion

November 1, 2003

Last Updated

May 1, 2013

Record last verified: 2013-04

Locations

US(1)