UNASSIGNED: 8512 Background: In Phase I/II studies, T and the combination of T+C each demonstrated promising activity against recurrent @entity521 , so a randomized study was performed. METHODS: Eligible @entity1 were <21 yrs with @entity66 at first recurrence after a first regimen of aggressive chemotherapy. 73 @entity1 had prior stem cell transplants. 13 @entity1 received "therapeutic window" @entity5532 for 3-6 weeks as part of the study. T+C received T 0.75mg/m2+C 250mg/m2+ @entity9614 150 mg/m2 daily*5d q21d. T received T 2.4mg/m2/d*5d q21d. Best response according to the International @entity521 Response Criteria was analyzed in a two-stage sequential design. In the calculation of time to @entity74 , @entity1 taken off study for stem cell transplant, refusal, or unrelated @entity204 were censored at that time. RESULTS: Target accrual 118, accrual 123, eligible 119 @entity1 (1996-2001). @entity137 was the same in both arms. @entity5532 had no effect on outcome. There were 11 (19%) CR+PR on T, 18 (31%) on T+C; 19 (32%) CR+PR+MR on T, 26 (45%) on T+C. At least eight more responders in T+C than in T were required by the two-stage design in order to conclude superiority of T+C; with only seven, there is insufficient evidence to reach such a conclusion. For both EFS and S treatment comparisons, the curves were not significantly different. However, the time to disease progression was significantly longer for T+C. The 2-year Progression-Free Survival rates (+/- standard error) were 16%+/-6% (T) vs. 36%+/-9% (T+C), p=0.0379. CONCLUSIONS: There is a trend toward better results with T+C than T. Incorporation of the combination into front line treatment plans deserves further exploration. No significant financial relationships to disclose.

Recurrent XXXX : Randomized treatment with topotecan + cyclophosphamide (T+C) vs. topotecan alone(T). A POG/CCG Intergroup Study.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['Hematopoietic toxicity'] @entity5532 :: ('MESH:D003676', 'Chemical') :: ['deferoxamine', 'Deferoxamine'] @entity66 :: ('MESH:D004194', 'Disease') :: ['evaluable disease'] @entity74 :: ('MESH:D030342', 'Disease') :: ['progressive disease'] @entity521 :: ('MESH:D009447', 'Disease') :: ['neuroblastoma', 'Neuroblastoma'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity9614 :: ('MESH:D015080', 'Chemical') :: ['MESNA']
@entity521 :: (MESH:D009447,Disease) :: ['neuroblastoma']
