Immunotoxin Therapy and Cytarabine in Treating Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

Description

This study will test different doses of combotox to find out what dose of this drug can be given safely to patients. Combotox will be given with cytarabine. Patients might have been given cytarabine as part of their treatment for ALL before; even if they have received cytarabine before, it usually still works when it is given if the leukemia has not completely disappeared with the first treatment (or is "refractory") or if the leukemia has come back (or has "relapsed"). Another purpose of this study is to find out what effects (good and bad) the experimental drug Combotox has on the patient and patient`s disease (ALL) when combined with cytarabine.

Study Start Date

April 2013

Estimated Completion Date

June 2016

Interventions

  • Drug: Combotox
  • Biological: Deglycosylated Ricin A Chain-Conjugated Anti-CD19/Anti-CD22 Immunotoxins
  • Drug: Cytarabine
  • Other: Pharmacological Study
  • Other: Laboratory Biomarker Analysis

Specialties

  • Oncology: Leukemia/Lymphoma,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology,Drug Trials

MeSH Terms

  • Leukemia, Lymphoid

Study ID

Montefiore Medical Center -- 11-04-146

Status

Unknown

Trial ID

NCT01408160

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

18

Sponsor

Montefiore Medical Center

Inclusion Criteria

  • Must have histologically confirmed B-lineage ALL at diagnosis and either evidence of relapse / refractory disease based on a Bone Marrow / Peripheral Blood examination or evidence by cytogenetic studies or PCR amplification.
  • Disease must be refractory to conventional induction therapy or relapsed after initial standard therapy for ALL. Up to five prior therapies are permitted and including allogeneic and/or autologous stem cell transplant
  • Minimum 18 years and maximum 65 years. Because no dosing or adverse event data are currently available on the use of Combotox in combination with Cytarabine in patients less than18 years of age, children are excluded from this study, but will be eligible for future pediatric phase 1 combination trials.
  • ECOG performance status less than 2
  • Life expectancy >2 months
  • Normal organ and marrow function as follows: total bilirubin less than 1.5 X institutional upper limit of normal, unless related to leukemic infiltration or hemolysis
  • AST(SGOT)/ALT(SGPT) less than 2.5 X institutional upper limit of normal, unless related to leukemic infiltration or hemolysis Creatinine within normal institutional limits OR Creatinine clearance greater than 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  • Must have recovered from effects of prior therapy. At least 2 weeks should have elapsed since the last dose of chemotherapy including steroids.
  • Adequate cardiac function defined as a shortening fraction of 27% by echocardiogram, or ejection fraction of 35-40% by MUGA scan and a QTc interval of less than or equal to 450ms for men and less than or equal to 460ms for women
  • Adequate pulmonary function defined as no evidence of dyspnea at rest.
  • Use of adequate contraception (hormonal or barrier method of birth control
  • abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

  • Chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
  • May not be receiving any other investigational agents
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to combotox or other agents used in study agents
  • Presence of a pleural effusion by chest x-ray
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic or active untreated CNS leukemia
  • History of mediastinal or total body irradiation
  • Presence of GVHD more than grade 2
  • History of documented seizure disorder, presence of cerebellar dysfunction, dysphasia or altered mental status on neurological examination
  • Human anti-mouse antibody (HAMA) levels of 100ÎŒg/ml
  • Impaired liver function defined as a total bilirubin greater than 1.5 x normal range and AST or ALT greater than 2.5 x normal range unless secondary to Gilbert's disease, hemolysis or leukemic involvement of the liver
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study
  • HIV-positive patients on combination antiretroviral therapy are ineligible

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
Albert Einstein College of Medicine - Bronx, New York 40.3 miles None None None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 125.3 miles None None None

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