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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 February 2013 |
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Main ID: |
NCT00002759 |
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Date of registration:
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01/11/1999 |
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Primary sponsor: |
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Public title:
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Irinotecan Plus Cyclosporine and Phenobarbital in Treating Patients With Solid Tumors or Lymphoma
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Scientific title:
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A PHASE I STUDY OF IRINOTECAN (CPT-11) WITH PHARMACOKINETIC MODULATION BY CYCLOSPORINE A AND PHENOBARBITAL |
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Date of first enrolment:
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June 1996 |
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Target sample size:
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3 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00002759 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Mark J. Ratain, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Chicago |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Malignant solid tumor or lymphoma refractory to standard therapy or for which no
therapy of proven benefit exists
- No leukemia
- Measurable or evaluable disease
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: Karnofsky 70-100%
- Life expectancy: At least 3 months
- WBC at least 3,500/mm3
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Hemoglobin at least 9 g/dL
- Bilirubin no greater than 1.5 mg/dL
- AST/ALT less than twice normal (unless due to disease)
- PT and PTT normal
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- No history of congestive heart failure requiring medical therapy
- No clinically significant or life threatening cardiac arrhythmia
- No history of significant pulmonary disease or lymphangitic lung disease
- No hypersensitivity to cyclosporine or cremophore
- No history of manifest or latent porphyria or hypersensitivity to barbiturates (for
parts of study using phenobarbital)
- No history of inflammatory bowel disease requiring therapy
- No chronic diarrhea syndrome or paralytic ileus
- No medical or psychiatric condition that precludes informed consent
- Not pregnant
- Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior biologic therapy
- At least 2 weeks since prior colony stimulating factors
- At least 4 weeks since prior chemotherapy (at least 6 weeks since nitrosoureas or
mitomycin)
- No prior bleomycin or irinotecan
- At least 4 weeks since prior radiotherapy to greater than 25% of bone marrow
- Minimum time interval between prior therapy and eligibility shortened by 2 weeks when
phenobarbital is administered
- Concurrent use of medications that affect the central nervous or cardiovascular
systems (e.g., anticonvulsants, calcium channel blockers, oral contraceptives) must
be approved by the Principal Investigator
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Drug/Agent Toxicity by Tissue/Organ
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Lymphoma
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Neutropenia
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Small Intestine Cancer
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Unspecified Adult Solid Tumor, Protocol Specific
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Intervention(s)
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Drug: cyclosporine
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Drug: irinotecan hydrochloride
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Drug: phenobarbital
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Secondary ID(s)
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CDR0000064707
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NCI-2012-02242
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NCI-T95-0100H
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UCCRC-8033
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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