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Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors medical trials happen in hundreds of localities throughout the U.S.A.. 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 does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors. Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors clinical trial. Participants frequently obtain the most expert healthcare available for their Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors  Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): EORTC Biological Therapeutics Development Study Group ,
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory solid tumors.
Details: OBJECTIVES: I. Determine the preliminary tolerability and safety of monoclonal antibody VEGF (MOAB VEGF) in patients with relapsed or refractory progressive solid tumors. II. Determine the optimum biologically active dose of MOAB VEGF for further evaluation based on exploratory methods. III. Determine the maximum tolerated dose of MOAB VEGF in these patients. IV. Determine a safe dose of MOAB VEGF for further clinical studies. V. Determine the dose limiting toxicity and pharmacokinetics of this regimen in these patients. VI. Determine the response rate in patients treated with this regimen. PROTOCOL OUTLINE: This is a dose escalation, multicenter study. Patients receive monoclonal antibody VEGF (MOAB VEGF) IV over 1 hour on days 1, 15, 22, and 29. Patients with partial response (PR), complete response (CR), or stable disease (SD) after completion of the fourth dose may receive weekly infusions for up to 6 months in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of MOAB VEGF until the maximum tolerated dose (MTD) and optimum biologically active dose (OBAD) are determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose limiting toxicity. The OBAD is defined as the dose at which vascular endothelial growth factor is optimally inhibited. Patients with PR, CR, or SD are evaluated every 6 weeks until disease progression or initiation of another treatment. Patients who discontinue treatment prematurely due to toxicity are followed weekly until resolution of any associated toxicity. Patients who discontinue treatment after the fourth dose of MOAB VEGF for any reason other than toxicity are followed every month for up to 6 months. PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven relapsed or refractory progressive solid tumor that is not amenable to treatment with standard therapies - No brain involvement or leptomeningeal disease --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy and recovered - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered - Endocrine therapy: At least 4 weeks since prior hormonal antitumor therapy; No concurrent steroids or hormonal therapy - Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Concurrent radiotherapy allowed - Surgery: Greater than 4 weeks since prior surgery except biopsy or fine needle aspiration of tumor masses - Other: At least 4 weeks since other prior investigational drugs or therapies; No other concurrent anticancer treatments; No other concurrent investigational therapy --Patient Characteristics-- - Age: 18 and over - Menopausal status: Postmenopausal - Performance status: ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL; No bleeding or clotting abnormalities - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST or ALT no greater than 2.5 times ULN; Alkaline phosphatase no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.4 mg/dL - Cardiovascular: Normal cardiac function by 12 lead ECG - Other: No unstable systemic disease or uncontrolled infection that would preclude study participation; No concurrent infection requiring antibiotics; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 70 days after study; No psychologic, familial, sociologic, or geographic condition that could preclude compliance; HIV negative; HTLV-1 negative; Hepatitis B surface antigen negative; No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix; No allergy to protein therapeutics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GordonJayson, Study Chair, EORTC Biological Therapeutics Development Study Group
Academisch Ziekenhuis Utrecht
Utrecht, , 3508 GA
Netherlands
University Hospital of Linkoping
Linkoping, , S-581 85
Sweden
Christie Hospital N.H.S. Trust
Manchester, England, M20 4BX
United Kingdom
Academisch Ziekenhuis Maastricht
Maastricht, , 6202 AZ
Netherlands
Additional Information:
Study ID Numbers: CDR0000067663; EORTC-13992,PDL-833-601
Study Start Date: December 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005061
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors
2. Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors
3. Combination Chemotherapy in Treating Patients With Advanced Cancer
4. E7070 in Treating Patients With Solid Tumors
5. BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other England Clinical Trials
Other Manchester Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Solid Tumors
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