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Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma 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 Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma conditions. Clinical Trials Search.org is a website committed 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 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 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 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 Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma clinical trial. Test subjects typically receive the most expert 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 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.
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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 Adult T-Cell Leukemia And Lymphoma Studies:
1. Chemotherapy and Radiation Therapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory T-cell Lymphoma, Hodgkin's Lymphoma, or Non-Hodgkin's Lymphoma
2. Interleukin-2 in Treating Patients With Mycosis Fungoides
3. Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
4. Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma
5. Combination Chemotherapy With or Without Etoposide in Treating Older Patients With Non-Hodgkin's Lymphoma
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Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma
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