Thalidomide and Temozolomide in Treating Young Patients With Relapsed or Progressive Brain Tumors or Recurrent Neuroblastoma
This study has been completed.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Children's Hospital Boston
Celgene Corporation
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00098865
First received: December 8, 2004
Last updated: July 6, 2011
Last verified: July 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Neuroblastoma |
Drug: temozolomide Drug: thalidomide |
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: Treatment |
| Official Title: | A Phase II Pilot Study Of Thalidomide With Temozolomide In Patients With Relapsed Or Progressive Brain Tumors Or Neuroblastoma |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- Feasibility at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Evidence of biologic activity as measured by radiographic response at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Toxicity as assessed by CTC 2.0 during treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Radiographic techniques as markers of tumor response as assessed by perfusion and diffusion MRI at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- In vitro correlative studies as markers of tumor response as assessed by urine and blood angiogenesis marker evaluation at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2002 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: temozolomide
Dose escalation for tolerability
Other Name: Temodar
Drug: thalidomide
Dosage changes by tolerability, given every night
Other Name: Thalamid
OBJECTIVES:
Primary
- Determine the feasibility of thalidomide and temozolomide in pediatric patients with relapsed or progressive poor prognosis brain tumors or recurrent neuroblastomas.
Secondary
- Determine, preliminarily, biologic activity of this regimen in these patients.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: Patients receive oral temozolomide on days 1-5 and oral thalidomide on days 1-28. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed* diagnosis of 1 of the following:
Poor prognosis brain tumor
- Relapsed or progressive disease
- No curative therapy exists
Neuroblastoma
- Recurrent disease NOTE: *Histologic confirmation not required for brain stem glioma; patients with brain stem glioma must have clinical and radiographic evidence of disease
- Patients with brain stem glioma must have symptoms lasting < 3 months comprising cranial nerve deficits (often VI or VII) and/or ataxia and/or long tract signs
PATIENT CHARACTERISTICS:
Age
- 21 and under
Performance status
- Karnofsky 50-100% OR
- Lansky 50-100%
Life expectancy
- More than 2 months
Hematopoietic
- Hemoglobin ≥ 9.0 g/dL
- Platelet count > 75,000/mm^3
- WBC > 2,000/mm^3
- Absolute neutrophil count > 1,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 mg/dL
- SGOT and SGPT ≤ 2 times normal (SGOT ≤ 4 times normal for patients taking Zantac)
- Alkaline phosphatase ≤ 2 times normal
- No active hepatic disease ≥ grade 3
Renal
- Creatinine < 1.5 mg/dL OR
- Creatinine clearance ≥ 70 mL/min
- No active renal disease ≥ grade 3
Cardiovascular
- No active cardiac disease ≥ grade 3
Pulmonary
- No active pulmonary disease ≥ grade 3
Other
- Not pregnant or nursing
Fertile patients must use effective contraception during and for 4 weeks after study participation
- Willing and able to participate in the System for Thalidomide Education and Prescription Safety (S.T.E.P.S.^®) program
- No active psychiatric disease ≥ grade 3
PRIOR CONCURRENT THERAPY:
Biologic therapy
Prior biologic therapy allowed
- No prior thalidomide
Chemotherapy
Prior chemotherapy allowed
- No prior temozolomide
Endocrine therapy
- Concurrent steroids allowed
Radiotherapy
- Prior radiotherapy allowed
Surgery
- Prior surgery allowed
Other
- Concurrent antiseizure medications allowed
- No other concurrent investigational agents
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098865
Locations
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Children's Hospital Boston
Celgene Corporation
Investigators
| Study Chair: | Mark W. Kieran, MD, PhD | Dana-Farber Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Mark W. Kieran, MD, PhD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00098865 History of Changes |
| Other Study ID Numbers: | 01-279 DFCI, P30CA006516, CDR0000396780 |
| Study First Received: | December 8, 2004 |
| Last Updated: | July 6, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Dana-Farber Cancer Institute:
|
recurrent neuroblastoma childhood central nervous system germ cell tumor childhood high-grade cerebral astrocytoma childhood choroid plexus tumor childhood craniopharyngioma childhood infratentorial ependymoma childhood grade I meningioma childhood grade II meningioma childhood grade III meningioma |
childhood supratentorial ependymoma recurrent childhood brain stem glioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood ependymoma recurrent childhood medulloblastoma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood visual pathway and hypothalamic glioma recurrent childhood pineoblastoma |
Additional relevant MeSH terms:
|
Brain Neoplasms Nervous System Neoplasms Neuroblastoma Central Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Thalidomide Temozolomide Dacarbazine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents |
ClinicalTrials.gov processed this record on May 23, 2013