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A Phase I Study of Intravenous (Emulsion) Fenretinide (4-HPR, NSC 374551) in Children With Recurrent or Resistant Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), and Non-Hodgkin's Lymphoma (NHL) IND #70,058"


Phase 1
N/A
21 Years
Open (Enrolling)
Both
Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma

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Trial Information

A Phase I Study of Intravenous (Emulsion) Fenretinide (4-HPR, NSC 374551) in Children With Recurrent or Resistant Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), and Non-Hodgkin's Lymphoma (NHL) IND #70,058"


Fenretinide is a cytotoxic retinoid that has activity against a variety of cell lines in
vitro in a dose-related manner. The exact mechanism of fenretinide cytotoxicity in leukemia
and lymphoma cell lines is not known, but may include the de novo ceramide synthesis of
ceramides and the generation of reactive oxygen species. The malignancy-specific nature of
fenretinide-induced ceramides suggests that combinations of the drug with other ceramide
modulating agents may have a favorable therapeutic index.

In this study, the primary aims are to define the maximum tolerated dose, toxicity profile,
and pharmacokinetics of IV fenretinide when given continuously in pediatric patients with
ALL, AML, and NHL. The drug will be administered via a central venous or percutaneous
indwelling central catheter in an inpatient hospital setting.


Inclusion Criteria:



- Diagnosed with relapsed or refractory ALL, AML, or NHL

- Must have had two or more therapeutic attempts for treating/curing disease

- Must have fully recoved from acute toxic effects of all prior therapy

- Karnofsky of greater than 50% for older than 10 years of age and Lansky greater than
50% for younger than 10 years.

Exclusion Criteria:

- Grade 2 Pruritus or Rash (all forms)

- Grade 3 Dry Skin that is refractory to topical medical management

- Cardiac Fractional Shortening < 27% on echocardiogram

- Left Ventricular Ejection Fraction < 45% on echocardiogram

- Known allergy to egg products or soy bean oil

- Renal, Liver, and Pancreatic function:

- serum creatinine > 1.5X ULN

- direct bilirubin > 1.5X ULN

- ALT or AST > 2.5X ULN

- Serum trigylcerides > 2.5X ULN for age

- Lipase > 1.5X ULN for age

- History of pancreatitis

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine maximum tolerated dose

Outcome Time Frame:

end of study

Safety Issue:

Yes

Principal Investigator

Anna R Franklin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

SPOC2008-01

NCT ID:

NCT01187810

Start Date:

August 2010

Completion Date:

April 2014

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Lymphoblastic Leukemia
  • Non-Hodgkin's Lymphoma
  • leukemia,lymphoma
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104