SJG-136 in Treating Patients With Relapsed or Refractory Acute Leukemia, Myelodysplastic Syndromes, Blastic Phase Chronic Myelogenous Leukemia, or Chronic Lymphocytic Leukemia - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00301769

Purpose

RATIONALE: Drugs used in chemotherapy, such as SJG-136, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying the side effects and best dose of SJG-136 in treating patients with relapsed or refractory acute leukemia, myelodysplastic syndromes, blastic phase chronic myelogenous leukemia, or chronic lymphocytic leukemia.

Condition	Intervention	Phase
Leukemia Myelodysplastic Syndromes	Drug: SJG-136	Phase I

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

Drug Information available for: SJG136

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase 1 Study of SJG-136 in Patients With Advanced Leukemia

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

Primary Outcome Measures:

Dose limiting toxicity [ Designated as safety issue: Yes ]
Maximum tolerated dose [ Designated as safety issue: Yes ]
Pharmacokinetics [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacodynamics [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	December 2005
Estimated Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Establish the maximum tolerated dose of SJG-136 in patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) myelodysplastic syndrome (MDS), chronic myelogenous leukemia in blastic phase (CML-BP), or chronic lymphocytic leukemia (CLL).
Determine dose-limiting toxicities and pharmacokinetics of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive SJG-136 IV over 15 minutes on days 1-5. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of SJG-136 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. A total of 10 patients are treated at the MTD.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following hematologic malignancies:
- Acute myeloid leukemia
- Acute lymphoblastic leukemia
- Myelodysplastic syndromes
- Chronic myelogenous leukemia in blastic phase
- Chronic lymphocytic leukemia
Relapsed or refractory disease
- Primary resistance (i.e., failed to achieve a complete remission [CR] to a standard induction regimen) or relapsed after achievement of a CR
  - Must have documented failure to last cytotoxic regimen prior to study entry
No immediately available, potentially curable options (e.g., stem cell transplantation) available
No known CNS disease

PATIENT CHARACTERISTICS:

ECOG performance status ≤ 2
Bilirubin normal (unless elevated due to Gilbert's syndrome)
SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
Creatinine normal OR creatinine clearance ≥ 60 mL/min
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to SJG-136
HIV positivity allowed provided CD4 counts are normal with no AIDS-defining disease
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situations that would limit study compliance

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Recovered from prior therapy
More than 7 days since radiotherapy
No other anti-leukemia agents except hydroxyurea ≤ 5 grams/day ≤ 14 days prior to and during first course of treatment to control blood counts
No concurrent combination antiretroviral therapy for HIV-positive patients
No other concurrent anticancer agents
No other concurrent investigational agents
No concurrent prophylactic hematopoietic colony-stimulating factors
No epoetin alfa or hematopoietic colony-stimulating factors during the first course of study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301769

Locations

United States, Texas
M. D. Anderson Cancer Center at University of Texas	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Farhad Ravandi, 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:	CDR0000462379, MDA-2005-0607, NCI-6934
Study First Received:	March 9, 2006
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00301769
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent adult acute myeloid leukemia
previously treated myelodysplastic syndromes
blastic phase chronic myelogenous leukemia
recurrent adult acute lymphoblastic leukemia
secondary myelodysplastic syndromes
de novo myelodysplastic syndromes
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)
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
refractory chronic lymphocytic leukemia

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
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasm Metastasis
Acute myeloid leukemia, adult
Congenital Abnormalities
Acute myelocytic leukemia
Chronic lymphocytic leukemia
Myelodysplastic syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Diseases
Leukemia, B-cell, chronic
Myelodysplastic Syndromes
Myelodysplasia
Acute myelogenous leukemia
Myeloproliferative Disorders
Leukemia, Myeloid
Recurrence
Lymphatic Diseases
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, B-Cell
Bone Marrow Diseases
Lymphoproliferative Disorders

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Disease
Pathologic Processes

Neoplasms by Histologic Type
Immune System Diseases
Syndrome
Cell Transformation, Neoplastic

ClinicalTrials.gov processed this record on January 15, 2009