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Home > "M" Clinical Trials Conditions > Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy  Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
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 advanced solid tumors that have not responded to previous therapy.
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 pharmacokinetics of this regimen in these patients. - Determine whether induction of antibodies against recombinant viscumin occurs in these patients. - Determine whether immunological stimulation at the RNA level of immune cells occurs in patients treated with this regimen. - 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 study. Patients receive mistletoe lectin (recombinant viscumin) IV over 1 hour twice weekly. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 1-3 patients receive escalating doses of recombinant viscumin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 20% of patients experience dose-limiting toxicity during the first course. Additional patients are treated at 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 2.5 times ULN (5 times ULN if liver metastases present) - Alkaline phosphatase less than 2.5 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 participation - 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, biologic response modifiers, or colony-stimulating factors - No concurrent immunostimulating substances, colony-stimulating factors (except in life-threatening situations), biologic response modifiers, or monoclonal antibodies Chemotherapy: - At least 4 weeks since prior chemotherapy Endocrine therapy: - At least 4 weeks since prior hormonal therapy - At least 4 weeks since prior systemic steroids - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickSchoffski, Study Chair, Medizinische Hochschule Hannover
Centre Regional Rene Gauducheau *Recruiting*
Nantes-Saint Herblain, , 44805
France
Recruiting Contact Person 33-240679900
Medizinische Hochschule Hannover *Recruiting*
Hannover, , D-30625
Germany
Recruiting Patrick Schoffski 49-511-532-4077
Additional Information:
Study ID Numbers: CDR0000068222; EORTC-16002
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006354
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Paclitaxel and BMS-214662 in Treating Patients With Advanced Solid Tumors
2. GTI-2040 and Gemcitabine in Treating Patients With Metastatic or Unresectable Solid Tumors
3. Bryostatin 1 Plus Gemcitabine in Treating Patients With Advanced Cancer
4. Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
5. Gefitinib, Capecitabine, and Celecoxib in Treating Patients With Advanced Solid Tumors
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Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous Therapy
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