Overview

MEN-10755 in Treating Adults With Recurrent or Refractory Solid Tumors

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of MEN-10755 in treating adults who have recurrent or refractory solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Criteria
DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: WHO 0-2 Life Expectancy: At
least 3 months Hematopoietic: ANC at least 2,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 1.5 mg/dL Liver function tests no greater than 2 times
upper limit of normal (ULN) (unless related to liver metastases, then no greater than 5
times ULN) Renal: Creatinine no greater than 1.4 mg/dL Creatinine clearance at least 60
mL/min Cardiovascular: LVEF greater than 50% (measured by MUGA scan) Other: Not pregnant or
nursing Effective contraceptive method must be used during study No active bacterial
infections No other nonmaliganant diseases No history of alcoholism or drug abuse No
psychosis

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy within 4 weeks of study
Concurrent use of growth factors is allowed in cases of febrile neutropenia (prophylactic
use not allowed) Chemotherapy: No prior chemotherapy within 4 weeks of study No prior
nitrosoureas, mitomycin, or high dose carboplatin within 6 weeks of study Endocrine
therapy: No concurrent corticosteroids (unless approved by clinical investigator)
Radiotherapy: No prior radiotherapy within 4 weeks of study No prior extensive radiotherapy
within 6 weeks of study Surgery: Not specified Other: No prior experimental therapy No
prior anthracyclines or anthracenediones