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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000465217 | Registry Identifier | PDQ (Physician Data Query) | |
| MDA-2005-0249 |
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RATIONALE: Drugs used in chemotherapy, such as VNP40101M, 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/II trial is studying the side effects and best dose of VNP40101M and to see how well it works in treating patients with Richter syndrome or refractory or relapsed chronic lymphocytic leukemia or other lymphoproliferative disorders.
OBJECTIVES:
OUTLINE: This is a phase I dose-escalation study followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laromustine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | ||
| Toxicity | ||
| Efficacy |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
Fludarabine refractory or relapsed chronic lymphocytic leukemia (CLL)
Richter syndrome
Other refractory lymphoproliferative diseases
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Creatinine ≤ 2.0 mg/dL
AST and ALT ≤ 3 times upper limit of normal (ULN) (unless due to organ infiltration by disease)
Bilirubin ≤ 1.5 times ULN (unless due to Gilbert's syndrome)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No uncontrolled infection
No symptomatic coronary artery disease
No arrhythmia not controlled by medication
No uncontrolled, symptomatic congestive heart failure
No myocardial infarction within the past 3 months
No other uncontrolled illness
No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Bonny L. Johnson, RN, MSN | Vion Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
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| ID | Term |
|---|---|
| C483604 | laromustine |
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