A Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer

NCT00165451 | Completed Phase 2

• 1 other identifier: 01-046
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use a combination of four oral drugs (thalidomide, cyclophosphamide, etoposide and celecoxib) to treat patients with relapsed or progressive cancer. These drugs are expected to target the blood vessels that supply the tumors with what they need to grow.

Conditions

Neoplasms

Keywords

Relapsed tumors; Progressive Poor Prognosis Tumors; Thalidomide; Celecoxib; Etoposide; Cyclophosphamide

Outcome Measures

Primary Outcomes (1)

• To evaluate the feasibility of administering thalidomide, celecoxib, etoposide and cyclophosphamide for recurrent and poor prognosis tumors.

  6 months

Secondary Outcomes (3)

• To obtain preliminary evidence of biologic activity of these four orally administered

  6 months

• to evaluate and document side effects from chronic administration of these four drugs at the doses prescribed in this protocol

  6 months

• to evaluate different radiographic techniques as markers of tumor response.

  6 months

Interventions

Thalidomide DRUG

Oral administration once daily at night starting at 3mg/Kg for 6 months.

Celecoxib DRUG

Oral administration twice daily starting at 100mg/dose for 6 months.

Etoposide DRUG

Oral administration once daily at night starting at 50mg/m2 3 weeks on and 3 weeks off for 6 months.

Also known as: VP-16

Cyclophosphamide DRUG

Oral administration once daily at night starting at 3.5mg/m2 3 weeks on and 3 weeks off for 6 months.

Eligibility Criteria

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

You may qualify if:

• Patients with relapsed or progressive poor prognosis tumors for which no curative therapy exists.
• Histologic confirmation of disease at diagnosis or relapse.
• Brain stem glioma patients who have progressed after radiation therapy do not require histologic confirmation. Duration of symptoms at the time of diagnosis must be less than 3 months and should consist of cranial nerve deficits and/or ataxia and/or long tract signs.
• 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.
• No active uncontrolled cardiac, hepatic, renal, or psychiatric disease defined as ≥ grade 3 based on the common toxicity criteria.
• No known allergies to sulfonamides
• Adequate renal function: Serum Creatinine \< 1.5 mg/dl or creatinine clearance or GFR \> 70 ml/min.
• Adequate hepatic function: Total Bilirubin \< 1.5 mg/dl; SGOT, SGPT, Alk Phos \< 3x normal.(SGOT can be \< 4x normal for patients on Zantac).
• Adequate bone marrow reserve: Hgb \> 9.0 g/dl, Platelets \> 75,000/mm3 (transfusion independent),WBC \> 2000/mm3 and ANC \> 1000/mm3.
• Patients receiving steroids and/or anti-seizure medications are eligible for this study.

You may not qualify if:

• Patients must not be pregnant or nursing, and all patients of child bearing age (both male and female) must be willing to practice birth control during and for 2 months after treatment with thalidomide. If the patient is unable to use oral contraceptives for medical reasons, 2 different barrier methods may be used if approved by the treating physician.
• No concurrent use of other investigational agents.
• Patients that have received more than 2 months of oral therapy with any of the agents used in this study will be ineligible. Standard administration of IV etoposide and cyclophosphamide, usually administered in 3-week cycles is permitted.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Kieran MW, Turner CD, Rubin JB, Chi SN, Zimmerman MA, Chordas C, Klement G, Laforme A, Gordon A, Thomas A, Neuberg D, Browder T, Folkman J. A feasibility trial of antiangiogenic (metronomic) chemotherapy in pediatric patients with recurrent or progressive cancer. J Pediatr Hematol Oncol. 2005 Nov;27(11):573-81. doi: 10.1097/01.mph.0000183863.10792.d4.

  PMID: 16282886 RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Thalidomide; Celecoxib; Etoposide; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Mark W. Kieran, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: June 1, 2001
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

US (1)