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

Sponsor:	Dana-Farber Cancer Institute
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165451

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 II

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:

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

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

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

Other Name: VP-16

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

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.

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:

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.

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 February 09, 2012