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

NCT00462787 | Completed Phase 1

• 2 other identifiers: 07-012MSKCC-07012
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia

Keywords

acute undifferentiated leukemia; recurrent childhood acute lymphoblastic leukemia; recurrent childhood acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; recurrent adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose of clofarabine

  2 years

• Overall survival

  2 years

• Progression-free survival

  2 years

Study Arms (1)

Clofarabine

EXPERIMENTAL

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.

Biological: filgrastim; Drug: clofarabine; Drug: dexamethasone; Drug: thiotepa; Drug: topotecan hydrochloride; Drug: vinorelbine tartrate

Interventions

filgrastim BIOLOGICAL

Clofarabine

clofarabine DRUG

Clofarabine

dexamethasone DRUG

Clofarabine

thiotepa DRUG

Clofarabine

topotecan hydrochloride DRUG

Clofarabine

vinorelbine tartrate DRUG

Clofarabine

Eligibility Criteria

• Age: Up to 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Biphenotypic, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Interventions

Filgrastim; Clofarabine; Dexamethasone; Thiotepa; Topotecan; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Nucleotides; Ribonucleotides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Peter G. Steinherz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Neerav Shukla, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: April 1, 2007
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

US (1)