Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT00098865|
Recruitment Status : Completed
First Posted : December 9, 2004
Results First Posted : September 25, 2014
Last Update Posted : October 7, 2014
RATIONALE: Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with temozolomide may kill more tumor cells.
PURPOSE: This phase II trial is studying the effectiveness of combining thalidomide with temozolomide in treating young patients who have relapsed or progressive brain tumors or recurrent neuroblastoma.
|Condition or disease||Intervention/treatment||Phase|
|Central Nervous System Tumor, Pediatric Neuroblastoma||Drug: temozolomide Drug: thalidomide||Phase 2|
- Determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas.
- Determine preliminarily evidence of biologic activity of this regimen in these patients.
- Determine the toxic effects of this regimen in these patients.
STATISTICAL DESIGN: The primary data analysis will estimate the percentage of patients who can complete 6 months of therapy in the mixed population. With a target accrual of 20 patients the 90% confidence for the true feasibility rate will be no wider than 40%.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
U.S. FDA Resources
Experimental: Thalidomide and Temozolomide
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression
The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.
Other Name: TemodarDrug: thalidomide
Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose.
Other Name: Thalamid
- Therapy Completion Rate [ Time Frame: 6 months ]Feasibility in this study was defined as completion of 6 months of thalidomide with temozolomide therapy. The corresponding therapy completion rate is defined as the proportion of patients who completed 6 months of therapy.
- Overall Response [ Time Frame: Assessed every 8 weeks while on treatment and every 3 months for one year off-study ]
Overall response is the best response during 6 months of therapy measured by radiographic response.
Complete Response (CR): Disappearance of all detectable tumors by imaging, if initially positive, as well as 2 consecutively negative CSF cytologic examinations (if the initial cytology was positive).
Partial Response (PR): > 50% reduction in the sum of the products of the maximum perpendicular diameter of all measurable lesions; or 2 consecutively negative CSF cytologies and a < 50% reduction in tumor size.
Stable Disease (SD): < 50% reduction in the sum of the products of the maximum perpendicular diameters of all measurable lesions, and persistently negative or positive CSF cytology Progressive Disease (PD): > 25% increase in the size of any measurable lesion, the appearance of a new radiographically demonstrable lesion, or the conversion of negative CSF cytology to positive, as confirmed by at least one repeat CSF cytology
- Overall Survival [ Time Frame: Assessed after treatment discontinued every 3 months up to 2 years. ]Time from registration to death. Patients alive at last follow-up were censored.
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 ClinicalTrials.gov identifier (NCT number): NCT00098865
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Mark W. Kieran, MD, PhD||Dana-Farber Cancer Institute|