17-Dimethylaminoethylamino-17-Demethoxygeldanamycin (17-DMAG) in Treating Patients With Metastatic Solid Tumors or Tumors That Cannot Be Removed By Surgery

• Status: Unknown status
• Trial end date: 1969-12-31
• 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 the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying the side effects and best dose of 17-DMAG in treating patients with metastatic solid tumors or tumors that cannot be removed by surgery.

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

Details

• Lead Sponsor: Institute of Cancer Research, United Kingdom
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumor

• Unresectable or metastatic disease

• Standard curative or palliative measures do not exist OR are no longer effective OR patient refused such measures

• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• More than 12 weeks

Hematopoietic

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

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9.0 g/dL

Hepatic

• Bilirubin normal

• ALT and AST ≤ 1.5 times upper limit of normal

• No chronic liver disease

• Hepatitis B or C negative

Renal

• Creatinine normal OR

• Creatinine clearance normal

Cardiovascular

• No symptomatic New York Heart Association class III-IV cardiac disease

• No myocardial infarction within the past year

• No active ischemic heart disease within the past year

• No poorly controlled angina

• No uncontrolled dysrhythmia or dysrhythmias requiring antiarrhythmic drugs

• No transient ischemic attack

• No stroke

• No peripheral vascular disease

• No congenital long QT syndrome

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

• QTc < 450 msec (for men) and 470 msec (for woman)

• LVEF > 40% by MUGA

• No left bundle branch block

Pulmonary

• No symptomatic pulmonary disease requiring medication, including any of the following:

• Dyspnea with or without exertion

• Paroxysmal nocturnal dyspnea

• Oxygen requirement

• Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception 4 weeks before, during, and for 6 months after completion of study treatment

• No known HIV positivity

• No other malignancy within the past 5 years except adequately treated cone biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

• No ongoing or active infection

• No diabetes mellitus (with evidence of severe peripheral vascular disease or ulcers)

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

• No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 4 weeks since prior immunotherapy

• Concurrent epoetin alfa allowed

Chemotherapy

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• No prior 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)

Endocrine therapy

• More than 4 weeks since prior endocrine therapy

• Concurrent luteinizing hormone-releasing hormone analogues for androgen-insensitive prostate cancer and rising prostate-specific antigen allowed

Radiotherapy

• More than 4 weeks since prior radiotherapy (except for palliative treatment)

• No prior irradiation field that potentially included the heart (e.g., mantle)

Surgery

• Not specified

Other

• Recovered from all prior therapy

• Concurrent bisphosphonates allowed

• At least 5 half-lives since prior and no concurrent medication that prolong QTc

• No other concurrent anticancer or investigational agents

• No concurrent grapefruit juice