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Home > "5" Clinical Trials Conditions > 506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma



506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

For Condition: recurrent adult acute lymphoblastic leukemia,T-cell adult acute lymphoblastic leukemia,recurrent adult lymphoblastic lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractoryT-cellacute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
Details: OBJECTIVES: - Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority. - Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients. - Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients. OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for one year and then every 6 months until death. PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma - Tumor cells should exhibit phenotypic characteristics of these diseases - No CNS involvement requiring intrathecal or craniospinal radiotherapy - Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - ECOG 0-3 OR - Karnofsky 40-100% Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 50 mL/min Other: - No neuropathy grade 2 or higher - No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy - No active seizure disorder - No active infection - No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior bone marrow transplantation allowed - No concurrent allogeneic bone marrow transplantation Chemotherapy: - At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered - No prior 506U78 Endocrine therapy: - No concurrent systemic steroid therapy Radiotherapy: - See Disease Characteristics - Prior radiotherapy allowed Surgery: - Not specified Other: - No other concurrent investigational therapy - No concurrent treatment for seizures
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AnthonyMurgo,  Study Chair,  National Cancer Institute (NCI)

Mayo Clinic Cancer Center *Recruiting*
Rochester,  Minnesota,  55905
United States
Recruiting Louis  Letendre 507-284-2511

Pharmaceutical Management Branch *Recruiting*
Rockville,  Maryland,  20852
United States
Recruiting Michelle  Plante 301-496-5725

Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia,  Pennsylvania,  19104-4283
United States
Recruiting Selina  Luger 215-662-6348

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Deborah  Thomas 713-745-4616

USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles,  California,  90033-0804
United States
Recruiting Alexandra  Levine 323-865-3913

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda,  Maryland,  20892-1182
United States
Recruiting Patient  Recruitment 301-496-4891

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Omer  Koc 216-244-1274

Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago,  Illinois,  60611
United States
Recruiting Martin  Tallman 312-695-4540

Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit,  Michigan,  48201-1379
United States
Recruiting Charles  Schiffer 313-745-8910


Additional Information:
Study ID Numbers:
  CDR0000066994;  CTEP-TRC-9701,CWRU-TRC-1499
Study Start Date: 
Record last reviewed: November 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003837

Other Recurrent Adult Acute Lymphoblastic Leukemia Studies:
1. 506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

2. Combination Chemotherapy in Treating Adults With Acute Lymphocytic Leukemia

3. 506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

4. Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia

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