Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I and Pharmacologic Study of 17-(Allylamino)-17-Demethoxygeldanamycin (AAG, NSC 330507) in Adult Patients With Solid Tumors
Phase I trial to study the effectiveness of geldanamycin analogue in treating patients who have advanced solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.
Status | Terminated |
Enrollment | 45 |
Est. completion date | |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
Criteria: - Platelet count at least 100,000/mm^3 - No leukemia - No active CNS involvement with tumor - ECOG 0-2 - Life expectancy: at least 3 months - Absolute neutrophil count at least 2,000/mm^3 - No New York Heart Association class III or IV heart failure - No history of myocardial infarction within the past year - Bilirubin =< upper limit of normal (ULN) - AST no greater than 2 times ULN (no greater than 98 U/L) - No uncontrolled dysrhythmias - No poorly controlled angina - No serious ventricular arrhythmia (i.e., ventricular tachycardia (VT) or ventricular fibrillation (VF) >= 3 beats in a row) - QTc interval =< 450 msec for men or =< 470 msec for women - LVEF >= 40% by MUGA - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No other serious medical condition that would preclude study participation - No serious hypersensitivity to egg products - No concurrent anticancer immunotherapy - At least 4 weeks since prior chemotherapy and recovered - No other concurrent anticancer chemotherapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] or mechlorethamine, vincristine, procarbazine, and prednisone [MOPP]) - No concurrent anticancer hormonal therapy - Concurrent glucocorticoids as antiemetics for nonmalignant disease allowed - At least 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy - No concurrent major surgery - No concurrent anticancer glucocorticoids - Creatinine =< ULN or Creatinine clearance at least 60 mL/min - No concurrent medications that cause QTc prolongation - Histologically confirmed advanced solid tumor for which no curative therapy exists - Non-Hodgkin's lymphoma allowed - No concurrent drugs that interfere with hepatic CYP3A4 metabolism (e.g., grapefruit juice, ketoconazole, fluconazole, itraconazole, cyclosporine, erythromycin, clarithromycin, cimetidine, terfenadine, astemizole, indinavir, or nelfinavir mesylate) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of tanespimycin | DLT are defined as any greater than or equal to grade 3 non-hematologic toxicity (except for alopecia of any grade, grade 3 nausea or vomiting during less than maximal antiemetic therapy, and grade 3 fever in the absence of neutropenia and infection), any grade 4 hematologic toxicity (except for anemia of any grade), or the inability to resume treatment by day 42 (longer than two week delay) because of drug related toxicity. | 28 days | No |
Secondary | Biomolecular effects of tanespimycin in normal tissues such as peripheral blood and bone marrow mononuclear cells | Changes in the protein expression of the molecular markers will be assessed by western blot analysis. | Up to day 5 | No |
Secondary | Pharmacokinetics of tanespimycin | Determined by HPLC with photodiode array detection. The pharmacokinetic parameters that will be determined for parent drug include the maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), area under the concentration-time curve (AUC), terminal half-life, clearance and volume of distribution. | Pre-infusion, 20 minutes, 40, 50, 60 (end of infusion), 70, 80, 95 and 110 minutes, and 2.5, 3, 4, 5, 6.5, 8, 10, 14 and 24 hours | No |
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