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

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00462787
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 28 Years
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
  • clofarabine — DRUG
  • dexamethasone — DRUG
  • thiotepa — DRUG
  • topotecan hydrochloride — DRUG
  • vinorelbine tartrate — DRUG

Study Details

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.

Key Dates

Start date
Apr 30, 2007
Status verified
Nov 2013
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Clofarabine
    This is a single arm phase I clinical trial to assess safety (morbidity and mortality) of a novel leukemia re-induction regimen. The first component of this trial is a phase I dose escalation study to determine the maximum tolerated dose (MTD) of the novel agent Clofarabine, when used in combination with topotecan, vinorelbine, thiotepa and dexamethasone. A total of three dose levels will be explored in this study.

Primary Outcome Measure

Maximum tolerated dose of clofarabine [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Memorial Sloan-Kettering Cancer Center· New York, NY

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