A Phase I Study of SJG-136 in Patients With Advanced Leukemia
Overview
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Overview
Brief Summary
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. 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.
Detailed Description
OBJECTIVES:
I. 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).
II. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •No immediately available, potentially curable options (e.g., stem cell transplantation) available
- •Bilirubin normal (unless elevated due to Gilbert's syndrome)
- •HIV positivity allowed provided CD4 counts are normal with no AIDS-defining disease
Exclusion Criteria
- •No known CNS disease
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to SJG-136
- •More than 7 days since radiotherapy
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other anti-leukemia agents except hydroxyurea =\< 5 grams/day =\< 14 days prior to and during first course of treatment to control blood counts
Arms & Interventions
Arm I
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.
Intervention: SJG-136 (Drug)
Outcomes
Primary Outcomes
Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Time Frame: 21 days
Secondary Outcomes
No secondary outcomes reported