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506U78 in Treating Patients With Refractory Hematologic Cancer
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Lymphoblastic Lymphoma T-cell Childhood Acute Lymphoblastic Leukemia | Drug: nelarabine Drug: methotrexate Drug: cytarabine Drug: therapeutic hydrocortisone | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Compound 506U78 in Patients With Refractory T-Cell Malignancies-POG/CCG Intergroup Study |
- Early marrow CR plus PR rate at day 21 [ Time Frame: Day 21 ]CR is defined by an M1 marrow which requires blast counts below 5%. PR is defined by an M2 marrow which requires blast counts below 25%.
- Remission duration [ Time Frame: Up to 2 years ]
- 6 month cumulative event-free survival [ Time Frame: 6 months ]
| Enrollment: | 148 |
| Study Start Date: | June 1997 |
| Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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. |
Drug: nelarabine
Given IV
Other Names:
Drug: methotrexate
Given IT
Other Names:
Drug: cytarabine
Given IT
Other Names:
Drug: therapeutic hydrocortisone
Given IT
Other Names:
|
Detailed Description:
OBJECTIVES:
I. Determine the response rate to compound 506U78 (2-amino-9-b-D-arabinofuranosyl-6-methoxy-9H-purine) administered as a 1 hour infusion daily for 5 days in patients with recurrent T-cell malignancies.
II. Determine the toxicities of compound 506U78 in this group of patients. III. Correlate the biochemical pharmacology of compound 506U78 (e.g., ara-G nucleotides in leukemic blasts and CSF concentrations) with clinical response.
IV. Determine the impact of compound 506U78 therapy on survival and duration of response of patients with recurrent T-cell malignancies.
OUTLINE: Patients are stratified according to disease characteristics: Group 1: T-cell ALL or NHL in first relapse (greater than 25% bone marrow blasts, with or without concomitant extramedullary relapse other than CNS); Group 2: T-cell ALL or NHL in second or later relapse (greater than 25% bone marrow blasts, with or without concomitant extramedullary relapse other than CNS); Group 3: T-cell ALL or NHL with positive bone marrow and CSF (greater than 5% bone marrow blasts and CNS 2 or 3 involvement); Group 4: Extramedullary relapse and less than 25% blasts in the bone marrow (excluding isolated CNS relapse)
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.
Eligibility| Ages Eligible for Study: | up to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00002970
| United States, California | |
| Children's Oncology Group | |
| Arcadia, California, United States, 91006-3776 | |
| Principal Investigator: | Stacey Berg | Children's Oncology Group |
More Information
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002970 History of Changes |
| Other Study ID Numbers: |
NCI-2012-01836 P9673 CCG-P9673 POG-9673 CDR0000065478 U10CA098543 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 1, 2013 |
Additional relevant MeSH terms:
|
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Methotrexate Cytarabine Hydrocortisone 17-butyrate 21-propionate Cortisol succinate Hydrocortisone acetate Hydrocortisone |
Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 22, 2017