NCT00004009

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of R115777 in treating patients who have refractory or recurrent acute leukemia or chronic myelogenous leukemia.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1999

Shorter than P25 for phase_1 leukemia

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

June 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

August 27, 2004

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

1.8 years

First QC Date

November 1, 1999

Last Update Submit

November 5, 2019

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiaadult acute promyelocytic leukemia (M3)secondary acute myeloid leukemia

Interventions

tipifarnibDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically proven leukemia of any of the following types: Acute myelogenous leukemia (AML) Newly diagnosed de novo AML in patients over 60 years with poor risk features Antecedent hematologic disorder Complex karyotypes or other adverse cytogenetics Stem cell immunophenotype AML arising from myelodysplastic syndrome Secondary AML Recurrent or refractory AML, including primary induction failure Acute lymphoblastic leukemia (ALL) Newly diagnosed de novo ALL in patients over 60 years with poor risk disease features Complex karyotype or other adverse cytogenetics Mixed lineage immunophenotype Recurrent or refractory ALL, including primary induction failure Chronic myelogenous leukemia in accelerated phase or blast crisis No more than 2 prior induction/reinduction therapy courses if failed primary induction therapy or relapsed following complete remission Not eligible for or refused allogeneic bone marrow transplantation Acute progranulocytic leukemia (M3) must meet following criteria: Prior treatment with tretinoin required No coagulopathy Low risk for developing coagulopathy No disseminated intravascular coagulation No CNS leukemia PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: No hyperleukocytosis (at least 50,000 leukemic blasts/mm3) Hepatic: Bilirubin normal SGOT and SGPT no greater than 2 times normal Renal: Creatinine no greater than 2 times normal Cardiovascular: LVEF at least 45% by MUGA or echocardiogram No myocardial infarction within the past 3 months No severe coronary artery disease No cardiomyopathy No congestive heart failure No prior coagulation related sequelae: Deep vein thrombosis Pulmonary embolus CNS thrombosis or bleed Other: No pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior growth factors (epoetin alfa, filgrastim, sargramostim, interleukin-3, interleukin-11) and recovered No prior allogeneic bone marrow transplantation No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy and recovered Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior extensive radiotherapy to greater than 25% bone marrow No concurrent radiotherapy 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 Iowa College of Medicine

Iowa City, Iowa, 52242, United States

Location

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Promyelocytic, Acute

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Study Officials

  • Judith E. Karp, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 27, 2004

Study Start

June 1, 1999

Primary Completion

April 1, 2001

Study Completion

April 1, 2001

Last Updated

November 7, 2019

Record last verified: 2019-11

Locations

US(3)