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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


Phase 1
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of becatecarin

Outcome Description:

Graded using the NCI CTCAE version 3.0.

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Francis Giles

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02609

NCT ID:

NCT00087204

Start Date:

May 2004

Completion Date:

Related Keywords:

  • 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
  • Congenital Abnormalities
  • Anemia
  • Anemia, Refractory
  • Anemia, Refractory, with Excess of Blasts
  • Blast Crisis
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Anemia, Aplastic

Name

Location
M D Anderson Cancer Center Houston, Texas  77030