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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165451
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : July 7, 2011
Information provided by:
Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Thalidomide Drug: Celecoxib Drug: Etoposide Drug: Cyclophosphamide Phase 2

Detailed Description:
  • Thalidomide will be given orally every evening and the daily dose will escalate until the patient reaches a dose on which they are comfortable and will given continuously for one year.
  • Celecoxib will be given orally twice a day and escalated as tolerated for one year.
  • Etoposide will be given orally once a day for 21 consecutive days. This medication will alternate with oral cyclophosphamide and will continue for one year.
  • Cyclophosphamide will be given orally once a day for 21 consecutive days and as stated above will alternate with etoposide for one year.
  • During the treatment, blood tests will be performed every three weeks except during the first 3 week cycle in which testing is performed every 2 weeks. Appropriate imaging studies will be performed every 9 weeks.
  • The duration of treatment is one year unless the side effects are too harmful or the tumor grows. Treatment may be continued past one year if the drugs are well tolerated and disease progression has not occured.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Anti-Angiogenic Chemotherapy: A Phase II Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer
Study Start Date : June 2001
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Thalidomide
    Oral administration once daily at night starting at 3mg/Kg for 6 months.
  • Drug: Celecoxib
    Oral administration twice daily starting at 100mg/dose for 6 months.
  • Drug: Etoposide
    Oral administration once daily at night starting at 50mg/m2 3 weeks on and 3 weeks off for 6 months.
    Other Name: VP-16
  • Drug: Cyclophosphamide
    Oral administration once daily at night starting at 3.5mg/m2 3 weeks on and 3 weeks off for 6 months.

Primary Outcome Measures :
  1. To evaluate the feasibility of administering thalidomide, celecoxib, etoposide and cyclophosphamide for recurrent and poor prognosis tumors. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. To obtain preliminary evidence of biologic activity of these four orally administered [ Time Frame: 6 months ]
  2. to evaluate and document side effects from chronic administration of these four drugs at the doses prescribed in this protocol [ Time Frame: 6 months ]
  3. to evaluate different radiographic techniques as markers of tumor response. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165451

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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
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Principal Investigator: Mark W. Kieran, MD, PhD Dana-Farber Cancer Institute
Publications of Results:
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Responsible Party: Mark Kieran, Dana-Farber Cancer Institute Identifier: NCT00165451    
Other Study ID Numbers: 01-046
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011
Keywords provided by Dana-Farber Cancer Institute:
Relapsed tumors
Progressive Poor Prognosis Tumors
Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents