17-DMAG in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphomas

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic or unresectable solid tumors or lymphomas. Drugs used in chemotherapy, such as 17-DMAG, work in different ways to stop cancer cells from dividing so they stop growing or die

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

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Histologically confirmed solid tumor or lymphoma

• Metastatic or unresectable disease

• Standard curative or palliative measures do not exist or are no longer effective

• No known brain metastases

• Performance status - ECOG 0-2

• Performance status - Karnofsky 60-100%

• More than 12 weeks

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9.0 g/dL

• ALT and AST ≤ 1.5 times upper limit of normal (ULN)

• Bilirubin ≤ normal

• Creatinine ≤ 1.25 times ULN

• Creatinine clearance ≥ 60 mL/min

• QTc < 450 msec for male patients (470 msec for female patients)

• LVEF > 40% by MUGA

• No history of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)

• No myocardial infarction or active ischemic heart disease within the past year

• No New York Heart Association class III or IV congestive heart failure

• No poorly controlled angina

• No uncontrolled dysrhythmia requiring medication

• No left bundle branch block

• No history of congenital long QT syndrome

• No other significant cardiac disease

• Pulse oximetry at rest or on exercise > 88%

• No symptomatic pulmonary disease (e.g., chronic obstructive or restrictive pulmonary disease, etc.) or any of the following are allowed:

• Pulmonary disease requiring medication

• History of dyspnea, dyspnea on exertion, or paroxysmal nocturnal dyspnea

• Patients meeting the Medicare criteria for home oxygen or are on oxygen

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study participation

• No uncontrolled illness

• No active or ongoing infection

• No history of allergic reaction attributed to compounds of similar chemical or biological composition to 17-dimethylaminoethylamino-17-demethoxygeldanamycin (17-DMAG)

• No psychiatric illness or social situation that would preclude study compliance

• No concurrent routine colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• Concurrent hormonal therapy allowed

• At least 4 weeks since prior radiotherapy and recovered

• No prior radiation that included the heart in the field (e.g., mantle)

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No other concurrent anticancer agents or therapies

• No concurrent medication that would prolong the QTc interval

• No other concurrent investigational agents