Geldanamycin Analogue in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

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

Summary

Phase I trial to study the effectiveness of geldanamycin analogue in treating patients who have advanced solid tumors or non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Criteria:

• Platelet count at least 100,000/mm^3

• No leukemia

• No active CNS involvement with tumor

• ECOG 0-2

• Life expectancy: at least 3 months

• Absolute neutrophil count at least 2,000/mm^3

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

• No history of myocardial infarction within the past year

• Bilirubin =< upper limit of normal (ULN)

• AST no greater than 2 times ULN (no greater than 98 U/L)

• No uncontrolled dysrhythmias

• No poorly controlled angina

• No serious ventricular arrhythmia (i.e., ventricular tachycardia (VT) or ventricular fibrillation (VF) >= 3 beats in a row)

• QTc interval =< 450 msec for men or =< 470 msec for women

• LVEF >= 40% by MUGA

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• No other serious medical condition that would preclude study participation

• No serious hypersensitivity to egg products

• No concurrent anticancer immunotherapy

• At least 4 weeks since prior chemotherapy and recovered

• No other concurrent anticancer chemotherapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] or mechlorethamine, vincristine, procarbazine, and prednisone [MOPP])

• No concurrent anticancer hormonal therapy

• Concurrent glucocorticoids as antiemetics for nonmalignant disease allowed

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

• No concurrent major surgery

• No concurrent anticancer glucocorticoids

• Creatinine =< ULN or Creatinine clearance at least 60 mL/min

• No concurrent medications that cause QTc prolongation

• Histologically confirmed advanced solid tumor for which no curative therapy exists

• Non-Hodgkin's lymphoma allowed

• No concurrent drugs that interfere with hepatic CYP3A4 metabolism (e.g., grapefruit juice, ketoconazole, fluconazole, itraconazole, cyclosporine, erythromycin, clarithromycin, cimetidine, terfenadine, astemizole, indinavir, or nelfinavir mesylate)