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506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004239
Recruitment Status : Terminated (poor accrual)
First Posted : January 29, 2004
Last Update Posted : July 4, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of 506U78 in treating patients who have hematologic cancer and kidney or liver impairment.

Condition or disease Intervention/treatment Phase
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Drug: Compound 506U78 Phase 1

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of 506U78 in patients with hematologic malignancies and renal or hepatic impairment. II. Establish dosing guidelines for this drug in this patient population. III. Determine the toxicities and pharmacokinetics of this drug in these patients.

OUTLINE: Patients are stratified into 5 groups according to renal and hepatic function: Group 1: Normal renal function and normal hepatic function Group 2: Moderate renal impairment and normal hepatic function Group 3: Severe renal impairment and normal hepatic function Group 4: End stage renal impairment and normal hepatic function Group 5: Normal renal function and moderate hepatic impairment Group 1: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Groups 2-5: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Dose escalation occurs independently in each of the treatment groups. Cohorts of 3-6 patients receive escalating doses of 506U78 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 toxicities. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Compound 506U78 (NSC #686673) in Patients With Hematologic Malignancies and Renal or Hepatic Impairment
Study Start Date : December 1999
Actual Primary Completion Date : January 2002
Actual Study Completion Date : January 2002

Arm Intervention/treatment
Experimental: Compound 506U78
Compound 506U78 will be administered intravenously over 2 hours on days 1, 3 and 5 of each 28 day treatment cycle.
Drug: Compound 506U78

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: Up to 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed hematologic malignancy that has failed standard therapy or for which no standard therapy exists, including, but not limited to, the following: Acute lymphocytic leukemia Acute myelogenous leukemia Chronic lymphocytic leukemia Chronic myelogenous leukemia Multiple myeloma Non-Hodgkin's lymphoma Hodgkin's disease No history of CNS disease, including carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin: Groups 1-4: Less than 1.5 times upper limit of normal (ULN) Group 5: 1.5-4 times ULN Renal: Creatinine clearance: Groups 1 and 5: Greater than 50 mL/min Group 2: 30-50 mL/min Group 3: Less than 30 mL/min Group 4: Less than 30 mL/min, requiring dialysis Neurologic: No history of grade 2 peripheral neuropathy No history of seizure disorder No history of neurologic dysfunction Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy (e.g., interferon, monoclonal antibodies) No concurrent interleukin-11 for treatment or prevention of thrombocytopenia No concurrent prophylactic colony stimulating factors Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for melphalan, carmustine, or mitomycin) At least 72 hours since prior hydroxyurea No prior 506U78 No other concurrent chemotherapy Endocrine therapy: At least 72 hours since prior glucocorticoids Concurrent continuation of steroids for adrenal failure allowed No concurrent hormones except for nondisease related conditions (e.g., insulin for diabetes) No concurrent dexamethasone or other steroidal antiemetics Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy No concurrent whole brain irradiation for documented CNS disease Surgery: Not specified Other: At least 72 hours since prior aspirin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004239

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United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Iowa
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
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Study Chair: Todd M. Zimmerman, MD University of Chicago
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Responsible Party: Alliance for Clinical Trials in Oncology Identifier: NCT00004239    
Other Study ID Numbers: CALGB-69803
U10CA031946 ( U.S. NIH Grant/Contract )
CDR0000067483 ( Registry Identifier: NCI Physician Data Query )
First Posted: January 29, 2004    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016
Keywords provided by Alliance for Clinical Trials in Oncology:
recurrent adult Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
refractory multiple myeloma
Waldenstrom macroglobulinemia
stage III multiple myeloma
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
polycythemia vera
primary myelofibrosis
essential thrombocythemia
refractory hairy cell leukemia
chronic myelomonocytic leukemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult T-cell leukemia/lymphoma
previously treated myelodysplastic syndromes
prolymphocytic leukemia
primary systemic amyloidosis
recurrent mantle cell lymphoma
anaplastic large cell lymphoma
recurrent mycosis fungoides/Sezary syndrome
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Myeloproliferative Disorders
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions