NCT00095797

Brief Summary

Phase I trial to study the effectiveness of XK469R in treating patients who have refractory hematologic cancer. Drugs used in chemotherapy, such XK469R, work in 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
60

participants targeted

Target at 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

October 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

2.4 years

First QC Date

November 9, 2004

Last Update Submit

February 7, 2013

Conditions

Adult Acute Basophilic LeukemiaAdult Acute Eosinophilic LeukemiaAdult Acute Megakaryoblastic Leukemia (M7)Adult Acute Minimally Differentiated Myeloid Leukemia (M0)Adult Acute Monoblastic Leukemia (M5a)Adult Acute Monocytic Leukemia (M5b)Adult Acute Myeloblastic Leukemia With Maturation (M2)Adult Acute Myeloblastic Leukemia Without Maturation (M1)Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Adult Acute Myelomonocytic Leukemia (M4)Adult Erythroleukemia (M6a)Adult Pure Erythroid Leukemia (M6b)Blastic Phase Chronic Myelogenous LeukemiaChronic Myelomonocytic Leukemiade Novo Myelodysplastic SyndromesPreviously Treated Myelodysplastic SyndromesRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRefractory Anemia With Excess BlastsRefractory Anemia With Excess Blasts in TransformationRefractory Chronic Lymphocytic LeukemiaRelapsing Chronic Myelogenous LeukemiaSecondary Myelodysplastic SyndromesStage III Chronic Lymphocytic LeukemiaStage IV Chronic Lymphocytic LeukemiaUntreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

  • MTD as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    21 days

  • Dose-limiting toxicity (DLT) defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications using CTCAE version 3.0

    21 days

Secondary Outcomes (2)

  • Pharmacokinetic profile of XK496R

    At baseline, at 15 and 30 minutes, and at 1, 2, 4, 6, 8, and 24 hours (of days 1-2), and at days 3 and 5

  • Candidate genes for XK469R using PCR assay

    At baseline

Study Arms (1)

Treatment (XK469R)

EXPERIMENTAL

Patients receive XK469R IV over 30-60 minutes on days 1, 3, and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: R(+)XK469Other: pharmacological studyOther: laboratory biomarker analysis

Interventions

R(+)XK469DRUG

Given IV

Also known as: XK469
Treatment (XK469R)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (XK469R)
laboratory biomarker analysisOTHER

Optional correlative studies

Treatment (XK469R)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of 1 of the following relapsed or refractory hematologic malignancies for which all potentially curative therapy options have been exhausted:
  • Acute myeloid leukemia\* (AML) (non-M3)
  • Acute lymphoblastic leukemia\*
  • Myelodysplastic syndromes\*, including the following:
  • Refractory anemia with excess blasts (RAEB)
  • RAEB in transformation
  • Chronic myelomonocytic leukemia in transformation\* (CMML-t) with ≥ 10% peripheral blood/bone marrow blasts
  • Chronic myelogenous leukemia in blast crisis\* (CML-BC)
  • Chronic lymphocytic leukemia
  • Rai stage III-IV
  • Failed prior fludarabine-based therapy and ≥ 1 other therapy
  • Fludarabine failure defined as failure to achieve partial response or complete response (CR) to at least 1 fludarabine-containing regimen; disease progression while on fludarabine; or disease progression within 6 months of response to fludarabine
  • Not a candidate for autologous or allogeneic stem cell transplantation (SCT)
  • Patients with previously untreated AML, MDS, or CMML-t who are considered inappropriate candidates for, or refused, standard induction chemotherapy due to older age or concurrent medical conditions are eligible
  • No known CNS disease
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Basophilic, AcuteLeukemia, Eosinophilic, AcuteLeukemia, Megakaryoblastic, AcuteLeukemia, Monocytic, AcuteLeukemia, Myeloid, AcuteCongenital AbnormalitiesLeukemia, Myelomonocytic, AcuteLeukemia, Erythroblastic, AcuteBlast CrisisLeukemia, Myelomonocytic, ChronicPrecursor Cell Lymphoblastic Leukemia-LymphomaAnemia, Refractory, with Excess of BlastsLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

XK 469

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMyeloproliferative DisordersBone Marrow DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyelodysplastic-Myeloproliferative DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAnemia, RefractoryAnemiaMyelodysplastic SyndromesLeukemia, B-Cell

Study Officials

  • Francis Giles

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

October 1, 2004

Primary Completion

March 1, 2007

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

US(1)