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Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma Clinical research trials and Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma. Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma clinical trial. Human subjects often get the best healthcare available for their Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma  Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma
Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma
For Condition: adult non-Hodgkin's lymphoma,adult Hodgkin's lymphoma,Cutaneous T-Cell Lymphoma,adult T-cell leukemia and lymphoma,adult solid tumor
Status: Recruiting
Sponsor(s): Stanford University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of gemcitabine by making cancer cells more sensitive to the drug. PURPOSE: Phase I trial to study the effectiveness of combining oblimersen with gemcitabine in treating patients who have metastatic or unresectablesolid tumors or lymphoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of oblimersen and gemcitabine in patients with advanced solid tumor or lymphoma. - Determine the effect of oblimersen on the pharmacokinetics and pharmacodynamics of gemcitabine in these patients. - Determine the toxic effects of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive oblimersen IV continuously on days 1-5 and gemcitabine IV over 2-3 hours on day 5. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oblimersen and gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients receive treatment at the MTD. PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study within 6-8 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignancy for which there is no standard or effective curative or palliative therapy - Solid tumors and lymphoma allowed - Metastatic or unresectable disease - Measurable or evaluable nonmeasurable disease - Evaluable nonmeasurable disease includes ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses not followed by CT scan or MRI, or cystic lesions - Disease characterized by elevated serum tumor marker alone is allowed - No known brain metastases PATIENT CHARACTERISTICS: Age - Over 18 Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - AST and ALT no greater than 2.5 times upper limit of normal - No history of portal hypertension - No history of cirrhosis or hepatitis - No radiographic evidence of cirrhosis and/or varices Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reaction attributed to compounds of similar chemical or biological composition to oblimersen or other study agents - No other concurrent uncontrolled illness that would preclude study participation - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent prophylactic colony-stimulating factors such as filgrastim (G-CSF) or sargramostim (GM-CSF) - Concurrent interventional growth factors allowed - No growth factor administration within 24 hours before study chemotherapy - Concurrent epoetin alfa allowed Chemotherapy - No more than 3 prior chemotherapy regimens - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy - More than 2 weeks since prior hormonal therapy - Concurrent megestrol for anorexia/cachexia allowed Radiotherapy - No prior pelvic or whole abdominal radiotherapy - More than 4 weeks since prior radiotherapy Surgery - More than 4 weeks since prior major surgery Other - Recovered from prior therapy - More than 4 weeks since prior investigational therapy - No prior oblimersen - No other concurrent investigational agents - No other concurrent anticancer therapy - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BranimirSikic, Study Chair, Stanford University
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5151
United States
Recruiting Branimir Sikic 650-723-7688
Additional Information:
Study ID Numbers: CDR0000299507; SUMC-NCI-5908,NCI-5908
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060112
Other Cutaneous T-Cell Lymphoma Studies:
1. Tipifarnib in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
2. Epirubicin and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
3. Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
4. Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma
5. Antineoplaston Therapy in Treating Patients With Low-Grade Non-Hodgkin's Lymphoma
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Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma
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