Clinical trial · Interventional

Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

Phase I Study of Dolastatin-10 in Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase

NCT00003693CI-TRIAL-00035456completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Dolastatin 10	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
MTD Group
interventionNames
1. Drug: Dolastatin 10

Primary outcomes (1)

measure
Maximum Tolerated Dose (MTD) of Dolastatin
timeFrame
Assessed with each 3 week cycle
description
Maximum tolerated dose defined by dose limiting toxicity of dolastatin.

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Dec 18, 1998
Primary completion: Oct 30, 2001
Completion: Oct 30, 2001
First posted: Mar 23, 2004
Last update posted: Oct 25, 2018
Enrollment: 30 (actual)
Lead sponsor: M.D. Anderson Cancer Center OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, previously treated myelodysplastic syndromes, childhood myelodysplastic syndromes

Data updated 22 days agoSource updated Oct 25, 2018source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.