|
Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer 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 and Tretinoin in Treating Patients With Hematologic Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer Clinical research trials and Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer 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 and Tretinoin in Treating Patients With Hematologic Cancer. Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer 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 and Tretinoin in Treating Patients With Hematologic Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer 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 and Tretinoin in Treating Patients With Hematologic Cancer  Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer
Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer
For Condition: Myelodysplastic Syndromes,adult acute myeloid leukemia,myelodysplastic and myeloproliferative disease,atypical chronic myeloid leukemia,Chronic Myelomonocytic Leukemia
Status: Recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal white blood cells. PURPOSE: Phase I trial to study the effectiveness of combining phenylbutyrate and tretinoin in treating patients who have hematologic cancer.
Details: OBJECTIVES: - Determine the safety and toxicity of phenylbutyrate and tretinoin in patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia. - Determine the pharmacokinetic interaction of this regimen in these patients. - Determine any potential therapeutic activity of this regimen in these patients. OUTLINE: This is a dose escalation study of tretinoin. Patients receive phenylbutyrate IV continuously on days 1-7 of weeks 1, 5, 7, 9, 11, 13, 15, 17, and 19. Patients also receive oral tretinoin three times daily on days 1-7 of weeks 3, 5, 7, 9, 11, 13, 15, 17, and 19. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tretinoin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose limiting toxicities. An additional cohort of 6 patients is accrued at the MTD. These patients receive phenylbutyrate IV continuously on days 1-3 of weeks 1 and 3-18. These patients also receive oral tretinoin three times daily on days 1-3 of weeks 2-18. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed myelodysplastic syndrome (MDS) - Refractory anemia - Primary refractory leukopenia or thrombocytopenia with morphologic features of MDS - Refractory anemia with excess blasts (RAEB) - Refractory anemia with ringed sideroblasts - RAEB in transformation - Must have excess blasts or be hematopoietically compromised, defined as one of the following: - RBC transfusion dependent - Granulocyte count less than 1,000/mm^3 - Platelet count less than 50,000/mm^3 OR - Diagnosis of chronic myelomonocytic leukemia - Hematopoietically compromised (as defined above) OR - Excess blasts OR - Evaluable disease related symptomatology (organomegaly or leukemia cutis) OR - Diagnosis of acute myeloid leukemia - WBC less than 20,000/mm^3 and stable for at least 2 weeks - Unlikely to require cytotoxic therapy during study - No CNS or pulmonary leukostasis or CNS leukemia PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - Hemoglobin at least 8 g/dL (transfusion allowed) - No disseminated intravascular coagulation Hepatic: - Bilirubin less than 2.0 mg/dL (unless due to hemolysis or Gilbert's syndrome) Renal: - Creatinine less than 2.0 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 2 weeks prior, during, and for 3 months after study - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 3 weeks since prior biologic therapy, including hematopoietic growth factors, and recovered Chemotherapy: - See Disease Characteristics - At least 3 weeks (1 month for MDS patients) since prior chemotherapy and recovered Endocrine therapy: - Not specified Radiotherapy: - At least 3 weeks since prior radiotherapy and recovered Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenGore, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Steven Gore 410-955-8781
Additional Information:
Study ID Numbers: CDR0000068164; NCI-T98-0068,JHOC-99072306,JHOC-J9879
Study Start Date:
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006239
Other Atypical Chronic Myeloid Leukemia Studies:
1. Fluconazole Compared With Voriconazole in Preventing Invasive Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Transplantation
2. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
3. Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
4. Bevacizumab in Treating Patients With Myelodysplastic Syndrome
5. Combination Chemotherapy With or Without Filgrastim and/or Tretinoin in Treating Patients With Acute Myeloid Leukemia
Related Studies:
Other atypical chronic myeloid leukemia Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer
|
|
|
|
|
|
|
|
