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Home > "I" Clinical Trials Conditions > Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors  Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
For Condition: Head and Neck Cancer,female reproductive cancer,Gastrointestinal Cancer,thorax and respiratory cancer,unclassified and other cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating advanced solid tumors. PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy in treating patients who have recurrentunresectable advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of SS1(dsFv)-PE38 immunotoxin in patients with advanced mesothelin-expressing malignancies. - Determine the toxic effects of this drug in these patients. - Determine the plasma pharmacokinetics of this drug in these patients. - Determine the response in patients treated with this drug. - Correlate the induction of antibody against this drug with its pharmacokinetics in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive a test dose of SS1(dsFv)-PE38 immunotoxin IV over 1-2 minutes on day 1 followed by SS1(dsFv)-PE38 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SS1(dsFv)-PE38 immunotoxin 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. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 3-15 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 confirmed advanced malignancy of 1 of the following types: - Ovarian cancer - All nonmucinous epithelial histologies are eligible - Primary peritoneal cavity cancer - Fallopian tube cancer - Malignant mesothelioma - No sarcomatous histology - Pancreatic cancer - Squamous cell cancer (SCC) of the lung - SCC of the cervix - SCC of the head and neck - Recurrent unresectable disease meeting 1 of the following criteria: - Previously treated with definitive standard therapy - Patient refused prior standard therapy - Initial or recurrent tumor positive (at least 30% of tumor cells) for mesothelin by immunohistochemistry - Measurable or evaluable disease - No clinically significant pericardial effusion - No known CNS or spinal cord involvement by tumor PATIENT CHARACTERISTICS: Age - 18 and over 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 75,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN - Albumin at least 3.0 g/dL - Hepatitis B and C negative Renal - Creatinine no greater than ULN - Calcium no greater than ULN Cardiovascular - No New York Heart Association class II-IV cardiovascular condition Pulmonary - Oxygen saturation of at least 93% on room air - DLCO at least 50% of predicted* - Total lung capacity and vital capacity at least 50% of predicted* - FEV_1 at least 50% of predicted* NOTE: *For patients with pleural mesothelioma and as clinically indicated Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No infection requiring parenteral antibiotics - No HIV infection - Serum neutralizing activity to SS1(dsFv)-PE38 immunotoxin (at 200 ng/mL) no greater than 75% PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 4 weeks since prior therapy and recovered - No other concurrent antitumor therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RaffitHassan, Study Chair, National Cancer Institute (NCI)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000316451; NCI-SS1PE-002,NCI-6221,NCI-03-C-0243
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066651
Other Unclassified And Other Cancer Studies:
1. Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
2. Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
3. Capecitabine Combined with Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
4. PV701 in Treating Patients With Advanced or Recurrent Peritoneal Cancer
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Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
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