Overview

Ifosfamide and Topotecan in Treating Patients With Refractory Solid Tumors

Status:
Completed
Trial end date:
2000-05-01
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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of chemotherapy with ifosfamide and topotecan in treating patients with refractory solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Ifosfamide
Isophosphamide mustard
Topotecan
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor Refractory disease;
not curable by surgery, radiation therapy, or standard chemotherapy Measurable or evaluable
disease required by evidence of radiographic abnormalities, abnormal physical exam, or
elevated tumor markers at least 3 times above normal No brain metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater
than 1.8 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater
than 60 mL/min Other: No medical or psychiatric conditions Not pregnant Adequate
contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior topotecan
or ifosfamide At least 4 weeks since myelosuppressive chemotherapy At least 6 weeks since
nitrosourea or mitomycin Must have recovered from prior therapy Endocrine therapy: Not
specified Radiotherapy: No prior radiation therapy to pelvis At least 4 weeks since
radiation therapy to major bone marrow containing areas Surgery: Must not have an option of
surgery for this disease