NCT00005967

Brief Summary

Randomized phase I trial to study the effectiveness of tipifarnib in treating patients who have advanced hematologic cancer. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-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

First Submitted

Initial submission to the registry

July 5, 2000

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Last Updated

February 11, 2013

Status Verified

October 1, 2004

Enrollment Period

3.7 years

First QC Date

July 5, 2000

Last Update Submit

February 8, 2013

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic Syndromes

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphomarefractory multiple myelomastage III multiple myelomastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiarefractory chronic lymphocytic leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiarefractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic 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 lymphomapreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesstage III mantle cell lymphomastage IV mantle cell lymphomarecurrent mantle cell lymphomapolycythemia veraprimary myelofibrosisessential thrombocythemiachronic eosinophilic leukemiachronic neutrophilic leukemiarecurrent 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)

Arm I

EXPERIMENTAL

Patients receive oral tipifarnib twice daily for 21 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 1 course of therapy, patients may receive subsequent therapy at the maximum tolerated dose at the investigator's discretion.

Drug: tipifarnib

Interventions

tipifarnibDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hematologic malignancy refractory to standard therapy or for which no known effective therapy exists * Hodgkin's or non-Hodgkin's lymphoma * Known bone marrow involvement * Acute myeloid leukemia * Chronic myelogenous leukemia * Chronic phase * No significant symptoms after treatment * No features of accelerated phase or blastic phase * Accelerated phase * WBC difficult to control with conventional busulfan or hydroxyurea in terms of dose requirement or shortening of intervals between courses * Rapid doubling of WBC (less than 5 days) * At least 10% blasts in blood or marrow * At least 20% blasts plus promyelocytes in blood or marrow * At least 20% basophils plus eosinophils in blood * Anemia or thrombocytopenia unresponsive to busulfan or hydroxyurea * Persistent thrombocytosis * Additional chromosome changes * Increasing splenomegaly * Development of chloromas or myelofibrosis * Blastic phase * At least 30% blasts plus promyelocytes in blood or bone marrow * Acute lymphoblastic leukemia * Chronic lymphocytic leukemia * Myelodysplastic syndromes * Refractory anemia with excess blasts (RAEB) * Chronic myelomonocytic leukemia * RAEB in transformation * Multiple myeloma * Chronic myeloproliferative diseases including, but not limited to, myelofibrosis with myeloid metaplasia * Measurable or evaluable disease documented by radiographic, hematologic, bone marrow, or clinical examination parameters * Refusal of allogeneic bone marrow transplantation allowed PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Hepatic: * Bilirubin no greater than 1.5 mg/dL * Albumin at least 2.5 g/dL Renal: * Creatinine less than 2.0 mg/dL Other: * No other uncontrolled medical disorder * No active inflammatory bowel disease, ileus, or other chronic malabsorption syndromes * Not pregnant or nursing * Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) * At least 3 days since prior hydroxyurea Endocrine therapy: * At least 4 weeks since prior systemic steroids for multiple myeloma Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * No prior total gastrectomy or total ileocolectomy Other: * No prior tipifarnib * No concurrent proton pump inhibitors (e.g., omeprazole)

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

Sponsors & Collaborators

Study Sites (1)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Related Publications (1)

  • Zimmerman TM, Harlin H, Odenike OM, Berk S, Sprague E, Karrison T, Stock W, Larson RA, Ratain MJ, Gajewski TF. Dose-ranging pharmacodynamic study of tipifarnib (R115777) in patients with relapsed and refractory hematologic malignancies. J Clin Oncol. 2004 Dec 1;22(23):4816-22. doi: 10.1200/JCO.2004.03.200.

    PMID: 15570084RESULT

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesHodgkin DiseaseLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, ChronicLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-CellPolycythemia VeraPrimary MyelofibrosisThrombocythemia, EssentialPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, ChronicLymphoma, B-Cell, Marginal Zone

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesAnemia, RefractoryAnemiaMyelodysplastic-Myeloproliferative DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteBlood Coagulation DisordersThrombocytosisBlood Platelet Disorders

Study Officials

  • Todd M. Zimmerman, MD

    University of Chicago

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

August 1, 2000

Primary Completion

April 1, 2004

Last Updated

February 11, 2013

Record last verified: 2004-10

Locations

US(1)