A Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165451
First received: September 9, 2005
Last updated: July 6, 2011
Last verified: July 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Neoplasms |
Drug: Thalidomide Drug: Celecoxib Drug: Etoposide Drug: Cyclophosphamide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Cyclophosphamide
Thalidomide
Etoposide
Etoposide phosphate
Celecoxib
U.S. FDA Resources
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To evaluate the feasibility of administering thalidomide, celecoxib, etoposide and cyclophosphamide for recurrent and poor prognosis tumors. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To obtain preliminary evidence of biologic activity of these four orally administered [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- to evaluate and document side effects from chronic administration of these four drugs at the doses prescribed in this protocol [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- to evaluate different radiographic techniques as markers of tumor response. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | June 2001 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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.
- 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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00165451
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
| Principal Investigator: | Mark W. Kieran, MD, PhD | Dana-Farber Cancer Institute |
More Information
Publications:
| Responsible Party: | Mark Kieran, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00165451 History of Changes |
| Other Study ID Numbers: | 01-046 |
| Study First Received: | September 9, 2005 |
| Last Updated: | July 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
Relapsed tumors Progressive Poor Prognosis Tumors Thalidomide |
Celecoxib Etoposide Cyclophosphamide |
Additional relevant MeSH terms:
|
Neoplasms Cyclophosphamide Thalidomide Etoposide phosphate Etoposide Celecoxib Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
ClinicalTrials.gov processed this record on May 16, 2013