ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
6-Hydroxymethylacylfulvene in Treating Patients With Refractory Myelodysplastic Syndrome, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Blastic Phase Chronic Myelogenous Leukemia

This study has been completed.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003997
  Purpose

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 6-hydroxymethylacylfulvene in treating patients who have refractory myelodysplastic syndrome, acute myeloid leukemia, acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Drug: irofulven
Phase I

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

ChemIDplus related topics:   6-(Hydroxymethyl)acylfulvene   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Study of MGI-114 (NSC#683863) in Patients With Refractory Myelodysplastic Syndromes, Acute Leukemia and Chronic Myelogenous Leukemia in Blastic Phase (CML-BP)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 1999

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose for 6-hydroxymethylacylfulvene in patients with refractory myelodysplastic syndrome, acute myeloid leukemia, acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia. II. Determine the qualitative and quantitative toxicities of this treatment in these patients. III. Determine the duration and reversibility of the qualitative and quantitative toxicities of this treatment in these patients. IV. Evaluate, in a preliminary manner, the antileukemic activity of this treatment in these patients. V. Assess relative mRNA levels of selected NER genes (ERCC1, ERCC2, and ERCC3) in tumor tissues of patients treated with this regimen and correlate with clinical outcome.

OUTLINE: This is a dose escalation study. 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. Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study at a rate of 2-4 patients per month.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within past 6 months Other: 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: Biologic therapy: At least 2 weeks since prior biologic therapy and recovered No concurrent systemic anticancer biologic therapy Chemotherapy: At least 2 weeks since other prior chemotherapy and recovered Concurrent hydroxyurea allowed if needed to control blast counts No concurrent systemic anticancer chemotherapy Endocrine therapy: At least 2 weeks since prior endocrine therapy and recovered Concurrent corticosteroids allowed if needed to control blast counts Radiotherapy: At least 2 weeks since prior radiotherapy and recovered No concurrent systemic radiotherapy Surgery: No concurrent surgery Other: At least 3 weeks since other prior investigational drugs (including analgesics or antiemetics) and recovered No other concurrent investigational drugs

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003997

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Francis J. Giles, MD     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067207, MDA-ID-99060, NCI-T99-0043
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003997
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute myeloid leukemia  
recurrent adult acute lymphoblastic leukemia  
blastic phase chronic myelogenous leukemia  
previously treated myelodysplastic syndromes  
secondary myelodysplastic syndromes  

Study placed in the following topic categories:
Blast Crisis
Leukemia, Lymphoid
Precancerous Conditions
Chronic myelogenous leukemia
Leukemia, Myeloid, Acute
Acute lymphoblastic leukemia, adult
Leukemia
Preleukemia
Neoplasm Metastasis
Acute myeloid leukemia, adult
Lymphoma
Acute myelocytic leukemia
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Myelodysplastic Syndromes
Myelodysplasia
Myeloproliferative Disorders
Acute myelogenous leukemia
Leukemia, Myeloid
Recurrence
Lymphatic Diseases
Irofulven
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Lymphoproliferative Disorders

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Disease
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms
Neoplastic Processes
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Syndrome
Antineoplastic Agents, Alkylating
Alkylating Agents
Cell Transformation, Neoplastic

ClinicalTrials.gov processed this record on September 19, 2008




Links to all studies - primarily for crawlers