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Anti-Angiogenic Chemotherapy: A Phase II Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer

Phase 2
21 Years
Not Enrolling

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Trial Information

Anti-Angiogenic Chemotherapy: A Phase II Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer

- 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.

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

- 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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Mark W. Kieran, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2001

Completion Date:

October 2006

Related Keywords:

  • Neoplasms
  • Relapsed tumors
  • Progressive Poor Prognosis Tumors
  • Thalidomide
  • Celecoxib
  • Etoposide
  • Cyclophosphamide
  • Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115