Clinical trial · Interventional
506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment
A Phase I Study of Compound 506U78 (NSC #686673) in Patients With Hematologic Malignancies and Renal or Hepatic Impairment
NCT00004239CI-TRIAL-00022828terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compound 506U78 | Drug | Nelarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Compound 506U78
- description
- Compound 506U78 will be administered intravenously over 2 hours on days 1, 3 and 5 of each 28 day treatment cycle.
- interventionNames
- Drug: Compound 506U78
Primary outcomes (1)
- measure
- Maximum tolerated dose
- timeFrame
- Up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.