Fenretinide in Children With Recurrent/Resistant ALL, AML, and NHL

NCT01187810 | Terminated Phase 1 DMC

• 1 other identifier: SPOC2008-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

The purposee of this study is to determine the safety and dosing of Fenretinide when given continuously for 5 days, every 3 weeks, in pediatric patients with recurrent and/or resistant acute lymphoblastic leukemia (ALL), acute myelogenous leukemia (AML), and non-Hodgkin's lymphoma (NHL).

Conditions

Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma

Keywords

leukemia,lymphoma

Outcome Measures

Primary Outcomes (3)

• Determine maximum tolerated dose

  end of study

• Define systemic toxicities

  end of study

• Determine plasma pharmacokinetics

  end of study

Secondary Outcomes (2)

• Determine the response rate to IV Fenretinide

  end of study

• Determine bioavailability of fenretinide and metabolites

  end of study

Study Arms (1)

Combination of Fenretinide, Cytarabine, and Methotrexate

EXPERIMENTAL

IV for 7 days for each 21 day cycle

Drug: Fenretinide; Drug: Cytarabine; Drug: Methotrexate

Interventions

Fenretinide DRUG

925 mg/m2 IV continuous infusion X 5 days for 6 cycles. Dose escalation will occur on a 3X3 basis.

Also known as: N-(4-hydroxyphenyl) retinamide, 4-HPR

Combination of Fenretinide, Cytarabine, and Methotrexate

Cytarabine DRUG

dosing depending on age - will be administed intrathecally for all CNS negative subjects on day 0 and 15 of course 1, then on day 8 of each remaining cycle for CNS negative AML. For CNS positive ALL, NHL, and AML, will be administered alone on day 0 for and in combination with methotrexate and hydrocortisone on day 8, 15, 22 of cycle 1 and repeated on day 8 of each remaining cycle

Also known as: Ara-C, Cytosine Arabinoside, Cytosar

Combination of Fenretinide, Cytarabine, and Methotrexate

Methotrexate DRUG

Dose depends on subject age - for CNS positive patients, will be given in combination with cytarabine and hydrocortisone on days 8, 15, and 22 during course 1. For courses 2-6, will be administered intrathecally on day 8 for CNS negative ALL and NHL. For patients who are CNS positive, it will be given in combination with cytarabine and hydrocortisone on day 8 of courses 2-6.

Also known as: MTX, Amethopterin

Combination of Fenretinide, Cytarabine, and Methotrexate

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• South Plains Oncology Consortium: lead

Study Sites (2)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin; Leukemia; Lymphoma

Interventions

Fenretinide; Cytarabine; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Anna R Franklin, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

• Barry J Maurer, MD, PhD

  Texas Tech University Health Sciences Center

  STUDY CHAIR

• Shengping Yang, PhD

  Texas Tech University Health Sciences Center

  STUDY DIRECTOR

• Min Kang, PharmD

  Texas Tech University Health Sciences Center

  STUDY DIRECTOR

• Patrick Reynolds, MD, PhD

  Texas Tech University Health Sciences Center

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 24, 2010
• Study Start: August 1, 2010
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

US (2)