Status:
COMPLETED
A Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Neoplasms
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
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 ...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00165451
Start Date
June 1 2001
End Date
October 1 2006
Last Update
July 7 2011
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115