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Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma Clinical research trials and Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma. Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "G" Clinical Trials Conditions > Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma  Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
For Condition: adult brain tumor,adult solid tumor,adult non-Hodgkin's lymphoma
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Gene therapy may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of combining gene therapy with chemotherapy in treating patients who have advanced solid tumors or non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Evaluate the feasibility of introducing and expressing mutant MGMT-G156A cDNA in hematopoietic progenitors taken from patients with advanced solid tumors (including gliomas) or non-Hodgkin's lymphoma using a safety modified retroviral vector MFG. - Determine the toxicity associated with reinfusion of ex vivo-transduced hematopoietic stem cells into these patients, including the detection of replication competent retrovirus. - Evaluate the feasibility of identifying mutant MGMT-G156A-transduced and O6-benzylguanine (BG)- and carmustine-resistant hematopoietic and stromal progenitors from the bone marrow of these patients. - Evaluate the feasibility of in vivo enrichment of the transduced hematopoietic progenitors in patients treated with BG and carmustine. - Evaluate the toxicity of this regimen in these patients. OUTLINE: This is a dose-escalation study of CD34 stem cells. After a negative bone marrow sampling, patients receive sargramostim (GM-CSF) and filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-5 (or G-CSF twice daily alone for 4-5 days). Peripheral blood progenitor cells are collected 24 hours after the last dose of growth factor injection on day 5 and also on day 6, if necessary. The CD34 positive stem cells are then infected by the retroviral mutant MGMT-G156A ex vivo. Patients receive O6-benzylguanine IV over 1 hour followed by carmustine IV over 1 hour every 6 weeks for 5 courses, assuming recovery of peripheral blood counts. Approximately 72 hours after the end of the first course of chemotherapy, patients receive reinfusion of retrovirally-transduced hematopoietic stem cells over 5-10 minutes. Cohorts of 3-6 patients receive escalating numbers of CD34 stem cells targeted for retroviral infection. Patients are followed monthly for 2 months, every 4 months for 8 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following histologically confirmed diseases for which no curative surgical, radiotherapy, or chemotherapy programs are available and standard therapy offers, at best, a modest clinical benefit - Solid tumors - Gliomas - Non-Hodgkin's lymphoma - Primary and metastatic CNS malignancies are eligible - Evaluable or measurable disease - No bone marrow involvement - Histologically negative bone marrow biopsy PATIENT CHARACTERISTICS: Age: - 18 to 70 Performance status: - ECOG 0-2 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8.5 g/dL Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST and ALT less than 2.5 times normal - Prothrombin time less than 1.2 times normal Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No acute cardiac disease by EKG Pulmonary: - DLCO at least 60% of predicted - No symptomatic pulmonary disease - Oxygen saturation on room air at least 90% by pulse oximetry - PO_2 at least 80% by arterial blood gases Other: - HIV negative - No other severe comorbid conditions - Not pregnant or nursing - Fertile patients must use effective contraception during and for 2 months after study completion PRIOR CONCURRENT THERAPY: Biologic therapy: - See Chemotherapy - No prior hematopoietic stem cell transplantation Chemotherapy: - No prior high-dose chemotherapy - No prior carmustine therapy - No more than 2 prior chemotherapy regimens for metastatic disease - Thalidomide and other non-myelosuppressive agents are not considered a prior regimen - Prior adjuvant chemotherapy allowed Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to 25% or more of bone marrow Surgery: - Not specified Other: - At least 4 weeks since prior myelosuppressive therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StantonGerson, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Omer Koc 216-244-1274
Additional Information:
Study ID Numbers: CDR0000066633; CWRU-2Y97,NCI-T97-0060
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003567
Other Adult Solid Tumor Studies:
1. Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
2. Diagnostic Study of Patients With Aggressive Non-Hodgkin's Lymphoma
3. Bortezomib in Treating Patients With Lymphoproliferative Disorders
4. Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Other B-cell Cancers
5. Combination Chemotherapy Followed By Radiation Therapy in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
Related Studies:
Other adult solid tumor Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Gene Therapy Plus Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
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