Combination Chemotherapy in Treating Children With Relapsed or Refractory Acute Lymphocytic Leukemia

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Terminated

CT.gov ID

NCT00003729

Collaborator

(none)

Enrollment

Locations

0.6

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have relapsed or refractory acute lymphocytic leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: cytarabine Drug: fludarabine phosphate Drug: idarubicin	Phase 2

Detailed Description

OBJECTIVES: I. Evaluate the complete response rate to combination fludarabine, idarubicin, and cytarabine in children with relapsed or refractory acute lymphocytic leukemia. II. Evaluate the safety and tolerance of this treatment in these patients. III. Evaluate the time to progression, disease free survival, and overall survival of these patients.

OUTLINE: This is an open label, multicenter study. Patients receive idarubicin IV over 1 hour on days 1-3. Fludarabine IV is administered over 30 minutes on days 1-5. Cytarabine IV is administered over 4 hours on days 1-5. If partial response is obtained, patients receive a second course of treatment. Patients receive a consolidation course in the absence of disease progression and unacceptable toxicity. Idarubicin IV is administered over 1 hour on days 1 and 2. Fludarabine IV is administered over 30 minutes, followed by cytarabine IV over 4 hours on days 1-5. Patients are followed every 3 months for 2 years or until death.

PROJECTED ACCRUAL: A total of 24-45 patients will be accrued for this study within 27 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Primary Purpose:

Treatment

Official Title:

Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children

Study Start Date :

Dec 1, 1998

Actual Primary Completion Date :

Apr 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Cytologically diagnosed relapsed or refractory acute lymphocytic leukemia previously treated with front line therapy FAB L1 or L2 Bone marrow relapse either isolated or associated with CNS or testicular relapse Bone marrow blast cells greater than 10% No isolated CNS relapse

PATIENT CHARACTERISTICS: Age: Under 18 Performance status: WHO 0-2 Play-performance scale at least 60% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2.5 times normal Renal: Creatinine less than 2.5 times normal Cardiovascular: No symptoms of cardiac failure No decline of ejection fraction by more than 20% of the lower limit of normal Shortening fraction at least 25% Other: No psychological, familial, sociological or geographical condition that would hamper compliance No uncontrolled infection

PRIOR CONCURRENT THERAPY: At least 6 months since prior autologous bone marrow transplantation No prior allogeneic bone marrow transplantation No concurrent treatment with other experimental drug

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Algemeen Ziekenhuis Middelheim	Antwerp	Belgium	2020
2	Hopital Universitaire Des Enfants Reine Fabiola	Brussels (Bruxelles)	Belgium	1020
3	Academisch Ziekenhuis der Vrije Universiteit Brussel	Brussels (Bruxelles)	Belgium	1090
4	Universitair Ziekenhuis Gent	Ghent (Gent)	Belgium	B-9000
5	U.Z. Gasthuisberg	Leuven	Belgium	B-3000
6	Centre Hospitalier Regional de la Citadelle	Liege (Luik)	Belgium	4000
7	Clinique de l'Esperance	Montegnee	Belgium	4420
8	Centre Hospitalier Regional et Universitaire d'Angers	Angers	France	49033
9	CHR de Besancon - Hopital Saint-Jacques	Besancon	France	25030
10	CHU de Caen	Caen	France	14033
11	CHR de Grenoble - La Tronche	Grenoble	France	38043
12	Centre Hospitalier Regional de Lille	Lille	France	59037
13	Hopital Debrousse	Lyon	France	69322
14	Hopital Arnaud de Villeneuve	Montpellier	France	34295
15	CHR Hotel Dieu	Nantes	France	44093
16	Centre Antoine Lacassagne	Nice	France	06189
17	Hopital Robert Debre	Paris	France	75019
18	Institut Curie - Section Medicale	Paris	France	75248
19	Hopital Jean Bernard	Poitiers	France	86021
20	Hopital Americain	Reims	France	51092
21	Hopital Universitaire Hautepierre	Strasbourg	France	67098
22	Hopital des Enfants (Purpan Enfants)	Toulouse	France	31026
23	Hospital Escolar San Joao	Porto	Portugal	4200