Anti-Angiogenic Chemotherapy:Oral 5-Drug Regimen in Patients With Relapsed or Progressive Cancer
Information source: Dana-Farber Cancer Institute
Information obtained from ClinicalTrials.gov on 2006-11-30
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Childhood Cancers
Intervention: Thalidomide (Drug); Celecoxib (Drug); Fenofibrate (Drug); Etoposide (Drug); Cyclophosphamide (Drug)
Phase: Phase 2
Status: Recruiting. Expecting to enroll 160 people.
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s):
Mark W Kieran, MD, PhD, Study Chair, Affiliation: Dana-Farber Cancer Institute
Overall contact:
Shannon Rice, BA, Phone: 617-632-5376, Email: shannon_rice@dfci.harvard.edu
Summary
The purpose of this study is to determine the effectiveness and side effects of adding fenofibrate to the combination of thalidomide, celecoxib, etoposide and cyclophosphamide in patients with relapsed or progressive cancer.
Clinical Details
Official title:
Anti-Angiogenic Chemotherapy: A Phase II Trial of the Oral 5-Drug Regimen (Thalidomide, Celecoxib, Fenofibrate, Etoposide and Cyclophosphamide) in Patients With Poor Prognosis, Relapsed or Progressive Cancer
Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Detailed description:
- One cycle of treatment is defined as 21 days and one course is defined as 3 cycles (9 weeks). Therapy will be divided into 3 courses.
- Thalidomide will be given orally at night and the dose wil be escalated every week as tolerated until the patient reaches a maximal dose on which they are comfortable and will be continuous for the duration of the study.
- Celecoxib will be give orally twice daily and escalated as tolerated. Celecoxib will also be given continuously throughout the study.
- Fenofibrate will be given orally once a day and escalated as tolerated for the duration of the study.
- Etoposide will be given orally once daily for 21 consecutive days and will alternate with cyclophosphamide.
- The total duration of the treatment is 27 weeks, but may be extended if no significant toxicity or disease progression occurs.
- Physical and neurologic examination and blood work will be obtained weekly for the first three weeks and every 3 weeks thereafter. Assessment of disease response will be done at the end of every course (9 weeks). This will include examination and radiographic evaluation.
- Post treatment follow-up will be done once a month for 2 months and includes blood work and examinations. Radiographic evaluations will be performed every third month for 6 months.
Eligibility
Maximum age: 21 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with relapsed or progressive poor prognosis tumor for which no available curative therapy exists.
- Patients should be ≤ 21 years of age at the time of study entry
- Histologic confirmation of disease at diagnosis or relapse. Disease categories will include the following strata: Leukemia/lymphoma, bone tumors (Ewing’s Sarcoma, Osteosarcoma), neuroblastoma, high-grade glial tumors, low-grade glial tumors, ependymomas, medulloblastoma/PNET, and miscellaneous.
- Brain stem glioma patients who have progressed after radiation therapy do not require histologic confirmation.
- Prior radiation therapy and/or chemotherapy are permitted.
- Karnofsky Performance Status ≥ 50. For infants, the Lansky play scale ≥ 50% can be substituted.
- Life expectancy > 2 months.
- Serum Creatinine < 1. 5 mg/dl or creatinine clearance or GFR ≥ 70 ml/min.
- Total Bilirubin ≤ 1. 5 mg/dl; SGOT, SGPT, Alk Phos ≤ 3x normal. (SGOT can be ≤ 4x normal for patients on Zantac).
- Hgb ≥ 9. 0 g/dl, Platelets >75,000/mm3 (transfusion independent), ANC > 1000/mm3 in patients without bone marrow disease.
- Patients receiving steroids and/or anti-seizure medications are eligible for this study.
Exclusion Criteria:
- Active uncontrolled cardiac, hepatic, renal, or psychiatric disease defined as ≥ grade 3 based on the common toxicity criteria. Patients with a history of significant gallbladder disease must be discussed with the PI prior to initiation of therapy.
- Allergies to sulfonamides (consisting largely of sulfa containing anti-microbials such as Bactrim/Septra; anti-malarials and some diuretics such as lasix, diomox).
- Pregnant or nursing women. All patients of child bearing age (both male and female) must be willing to practice birth control as
- Concurrent use of other investigational agents.
- Active infection
- Concurrent illness obscuring toxicity or dangerously altering drug metabolism
- Serious intercurrent medical illness
- Patients that have received more than 2 months of oral therapy with Etoposide, Thalidomide, Cyclophosphamide, or Fenofibrate will be ineligible.
Locations and Contacts
Shannon Rice, BA, Phone: 617-632-5376, Email: shannon_rice@dfci.harvard.edu
Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States; Recruiting
Eileen Gillan, MD, Phone: 860-545-9630, Email: egillan@ccmc.kids.org
Eileen Gillan, MD, Principal Investigator
A.I. duPont Hospital for Children, Wilmington, Delaware 19899, United States; Not yet recruiting
Andrew Walter, MD, Phone: 302-651-5515, Email: awwalter@nemours.org
Andrew Walter, MD, Principal Investigator
Miami Children's Hospital, Miami, Florida 33155, United States; Recruiting
Ziad Khatib, MD, Phone: 305-662-8360, Email: ziad.khatib@mch.com
Ziad Khatib, MD, Principal Investigator
Scottish Rite Children's Hospital, Atlanta, Georgia 30342, United States; Not yet recruiting
Claire Mazewski, MD, Phone: 404-785-3240, Email: claire.mazewski@choa.org
Claire Mazewski, MD, Principal Investigator
Children's Memorial Hospital, Chicago, Illinois 60614, United States; Recruiting
Stewart Goldman, MD, Phone: 773-880-4598, Email: sgoldman@northwestern.org
Stewart Goldman, MD, Principal Investigator
Maine Medical Center, Scarborough, Maine 04074, United States; Not yet recruiting
Tia Hamilton, MD, Phone: 207-885-7565, Email: ziad.khatib@mch.com
Tia Hamilton, MD, Principal Investigator
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
Mark W. Kieran, MD,PhD, Phone: 617-632-4907, Email: mark_kieran@dfci.harvard.edu
Shannon Rice, BA, Phone: 617-632-5376, Email: shannon_rice@dfci.harvard.edu
Mark W. Kieran, MD, PhD, Principal Investigator
Children's Hospital and Clinics-Mpls, Minneapolis, Minnesota 55118, United States; Not yet recruiting
Anne Bendel, MD, Phone: 612-813-5940, Email: anne.bendel@childrenshc.org
Anne Bendel, MD, Principal Investigator
Washington University School of Medicine, St. Louis, Missouri 63110, United States; Recruiting
Joshua Rubin, MD, PhD, Phone: 314-286-2790, Email: Rubin_J@kids.wustl.edu
Joshua Rubin, MD,PhD, Principal Investigator
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States; Not yet recruiting
Sara Chaffee, MD, Phone: 603-650-5541, Email: sara.chaffee@dartmouth.edu
Sara Chaffee, MD, Principal Investigator
Cancer Institute of New Jersey, New Brunswick, New Jersey 08903, United States; Recruiting
Wilbur Pan, MD, PhD, Phone: 732-235-6777, Email: panwi@umdnj.edu
Wilbur Pan, MD, PhD, Principal Investigator
New York University Medical School, New York, New York 10016, United States; Recruiting
Jeffrey Allen, MD, Phone: 212-263-6725, Email: jeffrey.allen@med.nyu.edu
Jeena Chacko, Phone: 212-263-2865, Email: jeena.chacko@nyumc.org
Jeffrey Allen, MD, Principal Investigator
University of Rochester Medical Center, Rochester, New York 14602, United States; Not yet recruiting
David Korones, MD, Phone: 716-275-2981, Email: david_korones@urmc.rochester.edu
David Korones, MD, Principal Investigator
Albany Medical Center, Albany, New York 12208, United States; Not yet recruiting
Joanne Porter, MD, Phone: 518-262-5513, Email: porterJ@mail.amc.edu
Joanne Porter, MD, Principal Investigator
University of Cincinnati, Cincinnati, Ohio 45202, United States; Not yet recruiting
Tim Cripe, MD,PhD, Phone: 513-636-4266, Email: timothy.cripe@chmcc.org
Tim Cripe, MD, Principal Investigator
UT Southwestern Medical School, Dallas, Texas 75390, United States; Not yet recruiting
Daniel Bowers, MD, Phone: 214-648-3896, Email: Daniel.Bowers@UTSouthwestern.edu
Daniel Bowers, MD, Principal Investigator
Additional Information
Starting date:
January 2005
Last updated: September 8, 2006
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