NCT00088868CompletedPhase 1
A Phase I Study Of 17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17DMAG) With Evaluation Of Hsp90 Client Proteins In Subjects With Solid Tumors And Lymphomas
National Institutes of Health Clinical Center (CC)2 sites in 1 country40 target enrollmentStarted: June 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG), work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with an advanced solid tumor or lymphoma.
Detailed Description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in patients with an advanced malignant solid tumor or lymphoma.
- Determine the dose-limiting toxic effects and toxicity profile of this drug in these patients.
Secondary
- Compare the effects of this drug on heat shock protein 90 (Hsp90) client proteins when assayed in peripheral blood mononuclear cells (PBMC) vs tumor tissue from patients treated with this drug.
- Correlate disturbances in key signaling pathways with administration of this drug in these patients.
- Determine the dose that alters key proteins in the majority of patients treated with this drug.
- Correlate serum proteomic patterns with target interactions or DMAG clinical effects in patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignant solid tumor OR lymphoma
- •Metastatic or unresectable disease
- •Standard curative or palliative measures are not available OR are associated with minimal survival benefit
- •No known brain metastases
- •Treated brain metastases allowed provided they have been stable ≥ 6 months without steroids or anti-seizure medications
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •WBC ≥ 3,000/mm^3
- •Hemoglobin > 8 g/dL
- •AST and ALT ≤ 2 times upper limit of normal
- •Bilirubin ≤ 1.5 times normal
- •PT and PTT ≤ 1.5 times normal (unless due to the presence of lupus anticoagulant or stable anticoagulation)
- •Creatinine normal OR
- •Creatinine clearance ≥ 60 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No orthostatic hypotension > grade 2 (requiring more than brief fluid replacement or other therapy OR with physiological consequences)
- •No New York Heart Association class III or IV heart failure
- •LVEF ≥ 40% by MUGA
- •QTc ≤ 450 msec (470 msec for women)
- •No congenital long QT syndrome
- •No myocardial infarction within the past year
- •No active ischemic heart disease within the past year
- •No history of uncontrolled dysrhythmias
- •No history of serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia > 3 premature ventricular contractions in a row)
- •Not requiring antiarrhythmic drugs
- •No poorly controlled angina
- •No left bundle branch block
- •No uncontrolled symptomatic pulmonary disease, including any of the following:
- •Dyspnea off or on exertion
- •Paroxysmal nocturnal dyspnea
- •Severe chronic obstructive/restrictive pulmonary disease requiring daily chronic medications and oxygen
- •Must not meet the Medicare criteria for home oxygen
- •No sufficiently compromised pulmonary status as measured by baseline pulmonary function tests and DLCO
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after study participation
- •No known HIV positivity
- •No hyponatremia indicated by sodium < 130 mmol/L
- •No known immunodeficiency syndromes
- +25 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
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