Overview

Dolastatin 10 in Treating Patients With Advanced Kidney Cancer

Status:
Completed
Trial end date:
2009-05-01
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. PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with advanced kidney cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Collaborator:
National Cancer Institute (NCI)
Treatments:
Dolastatin 10
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma considered incurable
by surgery and not amenable to radiation therapy with curative intent Locally advanced
disease OR Locally recurrent disease OR Metastatic disease No transitional cell carcinoma
Measurable disease No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST less than 3 times upper limit of
normal (ULN) Bilirubin normal Renal: Creatinine less than 1.5 times ULN Cardiovascular: No
New York Heart Association class III or IV heart disease Metabolic: Oral intake at least
1,200 calories per day Other: Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception No uncontrolled infection No known seizure
disorder No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix No other medical or psychiatric condition that would
interfere with compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy
No concurrent immunomodulating agents Chemotherapy: No prior chemotherapy for renal cell
carcinoma No other concurrent cytostatic or cytotoxic therapy Endocrine therapy: At least 4
weeks since prior hormonal therapy No concurrent hormonal agents Radiotherapy: See Disease
Characteristics At least 3 weeks since prior radiotherapy No prior radiotherapy to greater
than 15% of bone marrow No concurrent radiotherapy Surgery: See Disease Characteristics