|
Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System Clinical research trials and Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System. Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System clinical trial. Test subjects typically receive the most expert healthcare available for their Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System  Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System
Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System
For Condition: Brain Cancer
Status: No longer recruiting
Sponsor(s): Texas Children's Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of phenylbutyrate in treating children who have recurrent or progressive cancer of the central nervous system.
Details: OBJECTIVES: - Determine the therapeutic efficacy of phenylbutyrate in terms of response rate and time to progression in children with recurrent or progressive CNS malignancy. - Determine the toxicity of this regimen in these patients. - Determine the correlation between serum steady state phenylbutyrate levels and response or toxicity in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to tumor histology (high grade glioma (anaplastic astrocytoma or glioblastoma multiforme) vs brain stem glioma vs medulloblastoma or primitive neuroectodermal tumors vs other). Patients receive phenylbutyrate IV continuously on days 1-28. Treatment continues every 4 weeks for up to a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 week. PROJECTED ACCRUAL: A maximum of 120 patients (approximately 9-24 evaluable patients per stratum) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed recurrent or progressive brain tumor after radiotherapy, chemotherapy, or bone marrow transplantation - High grade glioma (anaplastic astrocytoma or glioblastoma multiforme) - Brain stem glioma - Medulloblastoma or primitive neuroectodermal tumors present in supratentorial or posterior fossa - Other - Histological confirmation waived in brain stem tumors - Patients previously treated with radiosurgery require a biopsy, PET scan or NMR spectroscopy - Measurable disease by CT or MRI imaging that clearly demonstrates recurrent or progressive nature of the lesion - Histologic evidence of bone marrow involvement allowed PATIENT CHARACTERISTICS: Age: - 2 to 21 Performance status: - Lansky 50-100% (10 and under) - Karnofsky 50-100% (over 10) Life expectancy: - At least 8 weeks Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3* - Platelet count at least 50,000/mm^3* - Hemoglobin at least 8.0 g/dL* NOTE: *Transfusion allowed Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGPT no greater than 2 times normal Renal: - Creatinine normal for age OR - Creatinine clearance at least 70 mL/min Other: - No other concurrent significant systemic illness (e.g., infection) - No significant electrolyte abnormalities - No amino acidurias or organic acidemias - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - Recovered from toxic effects of prior immunotherapy - Prior bone marrow transplantation allowed - No concurrent prophylactic hematopoietic growth factors except for neutropenia or documented infection Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) - Recovered from prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - If receiving dexamethasone must be on stable or decreasing dose for 2 weeks prior to study Radiotherapy: - See Disease Characteristics - Recovered from prior radiotherapy - More than 8 weeks since prior radiotherapy to evaluable lesion - More than 4 months since prior radiosurgery to evaluable lesion - Prior extensive radiotherapy (i.e., craniospinal radiotherapy or field encompassing region greater than hemipelvis) allowed Surgery: - See Disease Characteristics - See Radiotherapy Other: - No other concurrent investigational agents - Concurrent electrolyte supplements to maintain electrolyte levels allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanBlaney, Study Chair, Texas Children's Cancer Center
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94143-0128
United States
Texas Children's Cancer Center
Houston, Texas, 77030-2399
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4318
United States
Additional Information:
Study ID Numbers: CDR0000068163; TCCC-H-6321,TCCC-GCRC-0692,NCI-T98-0042,NCI-O1-C-0028
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006238
Other Brain Cancer Studies:
1. SU5416 in Treating Children With Recurrent or Progressive Brain Tumors
2. Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System
Related Studies:
Other Brain Cancer Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Phenylbutyrate in Treating Children With Progressive or Recurrent Cancer of the Central Nervous System
|
|
|
|
|
|
|
|
