Clinical trial · Interventional
506U78 in Treating Patients With Refractory Hematologic Cancer
A Phase II Study of Compound 506U78 in Patients With Refractory T-Cell Malignancies-POG/CCG Intergroup Study
NCT00002970CI-TRIAL-00011176completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Childhood Lymphoblastic Lymphoma | Childhood Lymphoblastic Lymphoma | CURATED_BROADER | 0.78 |
| T-cell Childhood Acute Lymphoblastic Leukemia | Childhood T Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| nelarabine | Drug | Nelarabine | ALIAS |
| therapeutic hydrocortisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- GROUP 1: Patients receive a 1 hour infusion of compound 506U78 daily for 5 days in the absence of neurologic toxicity. The course repeats every 21 days. If a first relapse T-cell ALL study of higher priority is not open, then the patient may continue to receive the drug every 21 days for a maximum of 2 years provided that the patient has achieved a second complete response. GROUPS 2 and 4: Patients receive compound 506U78 every 21 days for a maximum of 2 years, in the absence of disease progression. After 3 courses a patient may be given CNS prophylaxis with triple intrathecal therapy (TIT), consisting of methotrexate, cytarabine and hydrocortisone after consultation with study coordinator. TIT should be given every 12 weeks. GROUP 3: Patients receive compound 506U78 every 21 days for a maximum of 2 years, in the absence of disease progression. TIT will be given on day 1 of weeks 1-4, 6, 9 and every 6 weeks for 12 weeks, and then every 9 weeks thereafter. This stratum is open.
- interventionNames
- Drug: nelarabine
- Drug: methotrexate
- Drug: cytarabine
- Drug: therapeutic hydrocortisone
Primary outcomes (1)
- measure
- Early marrow CR plus PR rate at day 21
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Refractory or recurrent acute lymphocytic leukemia (ALL) or non-Hodgkin's lymphoma (NHL) with bone marrow involvement (T-cell disease only) * Isolated CNS relapse not eligible * Performance status - Karnofsky 50-100% * At least 8 weeks * Bilirubin no greater than 1.5 mg/dL * SGPT less than 5 times normal * Creatinine normal for age * Creatinine clearance or GFR at least 60 mL/min/1.73m2 * No severe uncontrolled infection * No concurrent biologic therapy * Recovered from toxic effects * At least 6 weeks from administration of nitrosoureas * No concurrent endocrine therapy * At least 6 weeks from administration of craniospinal or hemi pelvic radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.