17-Dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG) in Treating Patients With an Advanced Solid Tumor or Lymphoma

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)

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:

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