NCT00003693

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 dolastatin 10 in treating patients who have refractory or relapsed acute leukemia, chronic myelogenous leukemia in blast phase, or myelodysplastic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 leukemia

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 1998

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2001

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

March 23, 2004

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

November 1, 1999

Last Update Submit

October 23, 2018

Conditions

LeukemiaMyelodysplastic Syndromes

Keywords

recurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiablastic phase chronic myelogenous leukemiarefractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic leukemiapreviously treated myelodysplastic syndromeschildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of Dolastatin

    Maximum tolerated dose defined by dose limiting toxicity of dolastatin.

    Assessed with each 3 week cycle

Study Arms (1)

MTD Group

EXPERIMENTAL
Drug: Dolastatin 10

Interventions

Dolastatin 10DRUG

IV bolus once every 3 weeks.

MTD Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically diagnosed chronic myelogenous leukemia in blastic phase, refractory or relapsed acute leukemia, or myelodysplastic syndromes (refractory anemia with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia) PATIENT CHARACTERISTICS: Age: Not specified Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy and recovered (unless evidence of rapid disease progression) Endocrine therapy: Not specified Radiotherapy: Not specified 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 (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Related Links

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaBlast CrisisAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, Chronic

Interventions

dolastatin 10

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, MyeloidLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, RefractoryAnemiaMyelodysplastic-Myeloproliferative Diseases

Study Officials

  • Jorge Cortes, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 23, 2004

Study Start

December 18, 1998

Primary Completion

October 30, 2001

Study Completion

October 30, 2001

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

US(1)