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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

Primary Purpose

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)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
becatecarin
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (becatecarin)

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose of becatecarin
Graded using the NCI CTCAE version 3.0.

Secondary Outcome Measures

Survival
Time to progression
Time to treatment failure
Duration of response
Time to response

Full Information

First Posted
July 8, 2004
Last Updated
January 22, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00087204
Brief Title
Rebeccamycin Analog in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (becatecarin)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
becatecarin
Other Intervention Name(s)
BMS-181176, rebeccamycin analogue, rebeccamycin analogue, tartrate salt, XL119
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Maximum tolerated dose of becatecarin
Description
Graded using the NCI CTCAE version 3.0.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Survival
Time Frame
From date of first study drug administration to the date of death of the patients, assessed up to 3 years
Title
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
Title
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
Title
Duration of response
Time Frame
From the date of first objective response to the date of progression, assessed up to 3 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Giles
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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