Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Leukemia

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine, topotecan, vinorelbine, thiotepa, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with topotecan, vinorelbine, thiotepa, and dexamethasone in treating young patients with relapsed or refractory acute leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Clofarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Thiotepa; Topotecan; Vinblastine; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Must have 1 of the following diagnoses:

• Acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:

• Refractory to initial induction with two or more standard regimens

• Relapsed < 24 months after first complete response on a high-risk protocol OR refractory to one standard reinduction regimen

• Second or greater relapse

• Acute myeloid leukemia, acute biphenotypic leukemia, or acute undifferentiated leukemia meeting 1 of the following criteria:

• Refractory to initial induction

• First or greater relapse

• Must have > 20% bone marrow blasts, or evidence of recurrent disease at an extramedullary site

• No symptomatic CNS disease

• Patients with asymptomatic CNS disease are eligible with the approval of the principal investigator

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) 70-100% OR Lansky PS 70-100%

• AST and ALT < 4 times upper limit of normal

• Bilirubin < 2.0 mg/dL (unless liver involvement)

• Creatinine within normal range for age OR creatinine clearance > 60 mL/min/1.73 m^2

• Adequate cardiac function (either asymptomatic with no prior risk factors, or if symptomatic, left ventricular ejection fraction > 50% at rest)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active uncontrolled viral, bacterial, or fungal infection

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior clofarabine

• More than 2 weeks since prior systemic chemotherapy

• At least 7 days since prior chemotherapy for patients with rapidly progressive disease and recovered