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Mistletoe Lectin in Treating Patients With Refractory Advanced 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 Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors Clinical research trials and Mistletoe Lectin in Treating Patients With Refractory Advanced 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 Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors. Mistletoe Lectin in Treating Patients With Refractory Advanced 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 Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors clinical trial. Participants frequently obtain the most expert healthcare available for their Mistletoe Lectin in Treating Patients With Refractory Advanced 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 > Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors  Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors
Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): EORTC New Drug Development Group ,
Synopsis: RATIONALE: Mistletoe lectin may slow the growth of cancer cells and be an effective treatment for solid tumors. PURPOSE: Phase I trial to study the effectiveness of mistletoe lectin in treating patients who have refractory advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose and dose-limiting toxicity of mistletoe lectin (recombinant viscumin) in patients with advanced solid tumors who have failed standard therapy. - Determine the optimal biologically active dose of mistletoe lectin based on analysis of specific biological surrogate markers, including plasma cytokine levels and peripheral counts of activated immune cells and immunological stimulation at the RNA level of the immune cells. - Determine the pharmacokinetics of this regimen in these patients. - Determine whether induction of antibodies against mistletoe lectin occurs in these patients. - Determine whether modification of endothelial parameters occurs in patients treated with this regimen. - Determine the objective response rates in patients treated with this regimen. OUTLINE: This is a dose-escalation, multicenter study. Patients receive mistletoe lectin (recombinant viscumin) subcutaneously twice weekly. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of mistletoe lectin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the highest dose level immediately preceding the MTD. Patients are followed every 3 months until disease progression or initiation of another therapy. 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: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically proven progressive advanced solid tumor that is not amenable to standard therapy (i.e., resistant to standard therapy or for which no standard therapy exists) - No clinically symptomatic CNS involvement PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT less than 2 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase less than 2 times ULN (5 times ULN if liver metastases present) Renal: - Creatinine less than 1.4 mg/dL Cardiovascular: - No ECG abnormalities of clinical relevance Other: - No severe or unstable systemic disease or infection - No circumstances (e.g., alcoholism or substance abuse) that would preclude study - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior immunostimulating substances (e.g., biologic response modifiers or colony-stimulating factors) - No concurrent immunostimulating substances (e.g., biologic response modifiers or colony-stimulating factors (except in life-threatening situations)) Chemotherapy: - At least 4 weeks since prior chemotherapy Endocrine therapy: - At least 4 weeks since prior systemic steroids - At least 4 weeks since prior hormonal therapy - No concurrent systemic steroids Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - Not specified Other: - No prior mistletoe preparations - At least 4 weeks since prior investigational treatment - No other concurrent anticancer agents - No other concurrent investigational therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SteinarAamdal, , Norwegian Radium Hospital
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Contact Person 47-22-934-000
Klinikum der J.W. Goethe Universitaet *Recruiting*
Frankfurt, , D-60590
Germany
Recruiting Contact Person 49-69-6301-5253
Additional Information:
Study ID Numbers: CDR0000068304; EORTC-13001
Study Start Date:
Record last reviewed: February 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006477
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors
2. Interleukin-12 in Treating Patients With Advanced Cancer
3. Combination Chemotherapy in Treating Patients With Solid Tumors
4. Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors
5. Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors
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Mistletoe Lectin in Treating Patients With Refractory Advanced Solid Tumors
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