506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- Registration Number
- NCT00003545
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Phase II trial to study the effectiveness of 506U78 in treating patients with refractory or relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
- Detailed Description
OBJECTIVES:
I. Determine the complete and partial remission rates, as well as the remission duration, in patients with refractory or relapsed T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma receiving 506U78 on an alternate day schedule (days 1, 3, 5).
II. Determine the safety and toxicity of 506U78 administered on this schedule to this patient population.
OUTLINE:
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. If residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506U78. If day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response. For day 22 or 29 marrow that is in complete response, patients receive 506U78 for two more courses on days 1, 3, and 5, administered every 21 days. Patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm I nelarabine Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. If residual leukemia/lymphoma is present on day 22, then patients receive a second course of 506U78. If day 22 marrow is hypocellular, then a repeat bone marrow biopsy should be obtained on day 29 to assess response. For day 22 or 29 marrow that is in complete response, patients receive 506U78 for two more courses on days 1, 3, and 5, administered every 21 days. Patients are followed every 3 month for 1 year, then every 6 months for a maximum of 10 years.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (91)
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Hayden)
🇺🇸Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
🇺🇸Little Rock, Arkansas, United States
Cancer Center and Beckman Research Institute, City of Hope
🇺🇸Duarte, California, United States
Veterans Affairs Medical Center - Long Beach
🇺🇸Long Beach, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Scroll for more (81 remaining)MBCCOP - Gulf Coast🇺🇸Mobile, Alabama, United States