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Rebeccamycin Analog in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00087204
First Posted: July 12, 2004
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
This phase I trial is studying the side effects and best dose of rebeccamycin analog in treating patients with relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blast phase. Drugs used in chemotherapy, such as rebeccamycin analog, work in different ways to stop cancer cells from dividing so they stop growing or die

Condition Intervention Phase
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Blastic Phase Chronic Myelogenous Leukemia Chronic Myelomonocytic Leukemia de Novo Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Refractory Anemia With Excess Blasts Refractory Anemia With Excess Blasts in Transformation Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Drug: becatecarin Other: laboratory biomarker analysis Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study Of XL119 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphocytic Leukemia, Or Chronic Myeloid Leukemia In Blastic-Phase

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Maximum tolerated dose of becatecarin [ Time Frame: 21 days ]
    Graded using the NCI CTCAE version 3.0.


Secondary Outcome Measures:
  • Survival [ Time Frame: From date of first study drug administration to the date of death of the patients, assessed up to 3 years ]
  • Time to progression [ Time Frame: From the date of first study drug administration to the date that the patient is withdrawn because of clinical or radiographic progressive disease, or death from any cause, assessed up to 3 years ]
  • Time to treatment failure [ Time Frame: From the date of first study drug administration to the date of withdrawal from the study for any reason other than study closure, assessed up to 3 years ]
  • Duration of response [ Time Frame: From the date of first objective response to the date of progression, assessed up to 3 years ]
  • Time to response [ Time Frame: From the date of first study drug administration until the first objective documentation of response, assessed up to 3 years ]

Enrollment: 40
Study Start Date: May 2004
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (becatecarin)
Patients receive rebeccamycin analogue (XL119) IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive 1 additional course beyond CR. Patients achieving a PR or HI receive 2 additional courses beyond PR or HI. Cohorts of 3-6 patients receive escalating doses of XL119 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Drug: becatecarin
Given IV
Other Names:
  • BMS-181176
  • rebeccamycin analogue
  • rebeccamycin analogue, tartrate salt
  • XL119
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

OBJECTIVES:

I. Determine the maximum tolerated dose and dose-limiting toxicity of rebeccamycin analogue (XL119) in patients with relapsed or refractory acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, or chronic myelogenous leukemia in blastic phase.

OUTLINE: This is a dose-escalation study.

Patients receive rebeccamycin analogue (XL119) IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 1 additional course beyond CR. Patients achieving a partial response (PR) or hematologic improvement (HI) receive 2 additional courses beyond PR or HI. Cohorts of 3-6 patients receive escalating doses of XL119 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of 1 of the following:

    • Acute myeloid leukemia
    • Myelodysplastic syndromes, including 1 of the following:

      • Refractory anemia with excess blasts (RAEB)
      • RAEB in transformation
      • Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood or bone marrow blasts
    • Acute lymphoblastic leukemia
    • Chronic myelogenous leukemia in blastic phase
  • Relapsed or refractory disease, defined as 1 of the following:

    • Failed to achieve a complete response (CR) to a standard induction regimen
    • Relapsed after achieving a CR
  • Failed last cytotoxic regimen before study entry
  • No alternate, potentially curative option available
  • No known CNS disease
  • Performance status - ECOG 0-2
  • SGOT and SGPT normal
  • Bilirubin normal
  • Creatinine normal
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV-positive patients with normal CD4 count and without AIDS-defining disease allowed
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to rebeccamycin analogue (XL119)
  • No concurrent uncontrolled illness
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No prior allogeneic stem cell transplantation
  • No concurrent prophylactic hematopoietic colony-stimulating factors (CSF)
  • No epoetin alfa or hematopoietic CSF during course 1 of study therapy
  • More than 7 days since prior cytotoxic chemotherapy except for hydroxyurea
  • More than 7 days since prior radiotherapy
  • Recovered from all prior therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer agents or therapies
  • No other concurrent antileukemic agents or therapies
  • No other concurrent investigational agents or therapies
  • No other concurrent cytotoxic agents
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087204


Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Francis Giles M.D. Anderson Cancer Center
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00087204     History of Changes
Other Study ID Numbers: NCI-2012-02609
MDA-2003-0909
U01CA062461 ( U.S. NIH Grant/Contract )
CDR0000373813 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: July 8, 2004
First Posted: July 12, 2004
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myelomonocytic, Chronic
Syndrome
Anemia
Myelodysplastic Syndromes
Preleukemia
Neoplasm Metastasis
Anemia, Refractory
Blast Crisis
Anemia, Refractory, with Excess of Blasts
Anemia, Aplastic
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Neoplastic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases