Trial Search Results

T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)

Clofarabine is a drug approved by the FDA (Food and Drug Administration) for treating children (age 1-21) with leukemia. This research study will use clofarabine with two other cancer fighting drugs. Clofarabine will be used together with etoposide (VePesid®, VP-16) and cyclophosphamide (Cytoxan®).

Clofarabine, etoposide and cyclophosphamide have been used together in a phase I study to find out the highest doses of these drugs that can be safely given to children with relapsed or refractory leukemia. This study is a phase II study which will use the drugs to study how well these drugs work against AML. This study will also examine the safety of this drug combination.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Therapeutic Advances in Childhood Leukemia Consortium

Collaborator: Genzyme, a Sanofi Company

Intervention(s):

  • Drug: clofarabine
  • Drug: etoposide
  • Drug: cyclophosphamide
  • Drug: filgrastim
  • Drug: cytarabine

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Age: patients must be ≥ 1 and ≤ 21 years of age at the of study entry.

   - Diagnosis:

      - Patients must have a diagnosis of first or second relapse or refractory acute
      myelogenous leukemia (AML) according to WHO classification with ≥ 5% blasts in
      the bone marrow, with or without extramedullary disease. (See Appendix I)

      - Patients may have CNS 1 or CNS 2 disease but not CNS 3.

   - Performance Level: Karnofsky > 50% for patients > 16 years of age and Lansky > 50% for
   patients ≤ 16 years of age.

   - Prior Therapy:

      - Patients must have fully recovered from the acute toxic effects of all prior
      chemotherapy, immunotherapy, or radiotherapy prior to entering this study.

      - Patient has not received more than 2 previous induction attempts. (Frontline
      therapy is included in this count).

      - Patients must have adequate venous access.

      - At least 1 year must have elapsed since hematopoietic stem cell transplant (HSCT)
      and patients must not have active GVHD.

   - Reproductive Function

      - Female patients of childbearing potential must have a negative serum pregnancy
      test confirmed within 2 weeks prior to enrollment.

      - Female patients with infants must agree not to breastfeed their infants while on
      this study.

      - Male and female patients of child-bearing potential must agree to use an
      effective method of contraception approved by the investigator during the study
      and for a minimum of 6 months after study treatment.

   - Renal and Hepatic Function:

Patient must have adequate renal and hepatic functions as indicated by the following
laboratory values:

   - Patients must have a normal calculated creatinine clearance.

   - Total bilirubin <1.5 x ULN for age and conjugated/direct serum bilirubin ≤ ULN for age
   if total bilirubin is elevated.

   - Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 × ULN.

   - Alkaline phosphatase ≤ 2.5 × ULN.

      - Informed Consent: Patients and/or their parents or legal guardians must be
      capable of understanding the investigational nature, potential risks and benefits
      of the study. All patients and/or their parents or legal guardians must sign a
      written informed consent.

      - Protocol Approval: All institutional, FDA, and OHRP requirements for human
      studies must be met.

Exclusion Criteria:

   - Patients with Down Syndrome.

   - Prior treatment with Clofarabine.

   - Previous history of veno-occlusive disease (VOD) or findings consistent with a
   diagnosis of VOD, defined as: conjugated serum bilirubin > 1.4 mg/dL AND unexplained
   weight gain greater than 10% of baseline weight or ascites AND hepatomegaly or right
   upper quadrant pain without another explanation, OR reversal of portal vein flow on
   ultrasound, OR pathological confirmation of VOD on liver biopsy.

   - Patients who have a history of cirrhosis of the liver or who are positive for
   hepatitis B core antibody (anti-HBc) or have a positive test for hepatitis C antibody
   (anti-HCV).

   - Patient has received TBI.

   - If it has been less than 1 year since the patient had a HSCT.

   - Infection Criteria

      - Patients with a systemic fungal, bacterial, viral, or other infection not
      controlled (defined as exhibiting ongoing signs/symptoms related to the infection
      and without improvement, despite appropriate antibiotics or other treatment).

      - Positive blood culture within 48 hours of study registration.

      - Patient required supplemental oxygen or vasopressors within 48 hours of study
      (Oxygen after anesthesia for procedures is ok).

   - Patient is receiving or plans to receive concomitant chemotherapy, radiation therapy,
   or immunotherapy other than as specified in the protocol.

   - Use of investigational agents within 30 days or any anticancer therapy within 2 weeks
   before planned drug initiation with the exception of hydroxyurea or intrathecal
   therapy given with the diagnostic lumbar puncture.

   - Have any other severe concurrent disease, or have a history of serious organ
   dysfunction or disease involving the heart, kidney, liver, or other organ system that
   may place the patient at undue risk to undergo treatment.

   - Pregnant or lactating patients.

   - Any significant concurrent disease, illness, psychiatric disorder or social issue that
   would compromise patient safety or compliance, interfere with consent, study
   participation, follow up, or interpretation of study results.

   - Have had a diagnosis of another malignancy, unless the patient has been disease-free
   for at least 3 years following the completion of curative intent therapy with the
   following exceptions:

      - Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical
      intraepithelial neoplasia, regardless of the disease-free duration, are eligible
      for this study if definitive treatment for the condition has been completed.

      - Patients with organ-confined prostate cancer with no evidence of recurrent or
      progressive disease based on prostate-specific antigen (PSA) values are also
      eligible for this study if hormonal therapy has been initiated or a radical
      prostatectomy has been performed.

Ages Eligible for Study

1 Year - 21 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs
650-723-5535
Not Recruiting