Status:
COMPLETED
17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in Treating Patients With an Advanced Solid Tumor or Lymphoma
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Small Intestine Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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. PU...
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. * Determin...
Eligibility Criteria
Inclusion
- 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:
- Age
- 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
- Hepatic
- 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)
- Renal
- 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
- Pulmonary
- 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
- Other
- 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
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to 17-dimethylaminoethylamino-17-demethoxygeldanamycin (geldanamycin or 17-AAG)
- No concurrent uncontrolled illness
- No active or ongoing uncontrolled infection
- No psychiatric illness or social situation that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 4 weeks since prior biologic therapy and recovered
- No concurrent prophylactic growth factors
- Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin, 8 weeks for UCN-01) and recovered
- Endocrine therapy
- See Disease Characteristics
- Concurrent hormonal therapy for prostate cancer allowed provided patient has metastatic disease that has progressed despite prior hormonal therapy
- Radiotherapy
- More than 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy that included the heart in the field (e.g., mantle radiotherapy)
- Surgery
- At least 4 weeks since prior major surgery
- Other
- At least 2 weeks since prior participation in a phase 0 study
- Concurrent bisphosphonates for any cancer allowed
- Concurrent preventative doses of aspirin or non-steroidal anti-inflammatory drugs allowed
- No concurrent drugs that may prolong QTc interval
- No concurrent full anticoagulation on a regular basis
- No concurrent prophylactic antiemetics
- No other concurrent investigational agents or therapies
- No other concurrent anticancer agents or therapies
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00088868
Start Date
June 1 2004
End Date
December 1 2010
Last Update
March 15 2012
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182