NCT00003997

Brief Summary

Phase I trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating patients who have refractory myelodysplastic syndrome, acute myeloid leukemia, acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia. 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
25

participants targeted

Target at P25-P50 for phase_1 leukemia

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

July 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2000

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

June 3, 2004

Completed
Last Updated

February 8, 2013

Status Verified

January 1, 2001

Enrollment Period

1.3 years

First QC Date

November 1, 1999

Last Update Submit

February 7, 2013

Conditions

LeukemiaMyelodysplastic Syndromes

Keywords

recurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiablastic phase chronic myelogenous leukemiapreviously treated myelodysplastic syndromessecondary myelodysplastic syndromes

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive 6-hydroxymethylacylfulvene (HMAF) IV over 5 minutes on days 1-5. Treatment repeats every 3-4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of HMAF. The maximum tolerated dose is defined as the dose at which dose limiting toxicity occurs in at least 40% of patients.

Drug: irofulven

Interventions

irofulvenDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of refractory myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia MDS and AML include: * First salvage with primary refractory disease or first complete remission of no more than 12 months * Second or greater salvage * After the maximum tolerated dose is determined, AML patients with an intermediate prognosis (i.e., complete remission of more than 12 months, but less than 24 months) are eligible * No candidates for curative therapies such as allogeneic bone marrow transplantation PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: Zubrod 0-2 * Bilirubin no greater than 1.5 mg/dL * Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min * No active congestive heart failure * No uncontrolled angina * No myocardial infarction within past 6 months * No concurrent grade 4 infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No overt psychosis, mental disability, or other incompetency that would preclude obtaining informed consent * No life threatening nonmalignant illness PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior biologic therapy and recovered * No concurrent systemic anticancer biologic therapy * At least 2 weeks since other prior chemotherapy and recovered * Concurrent hydroxyurea allowed if needed to control blast counts * No concurrent systemic anticancer chemotherapy * At least 2 weeks since prior endocrine therapy and recovered * Concurrent corticosteroids allowed if needed to control blast counts * At least 2 weeks since prior radiotherapy and recovered * No concurrent systemic radiotherapy * No concurrent surgery * At least 3 weeks since other prior investigational drugs (including analgesics or antiemetics) and recovered * No other concurrent investigational drugs

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, United States

Location

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaBlast Crisis

Interventions

irofulven

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 Symptoms

Study Officials

  • Francis J. Giles, 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
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 3, 2004

Study Start

July 1, 1999

Primary Completion

October 1, 2000

Last Updated

February 8, 2013

Record last verified: 2001-01

Locations

US(1)