- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003914
Dolastatin 10 in Treating Patients With Advanced Kidney Cancer
Phase II Study of Dolastatin-10 in Patients With Advanced Renal Cell Carcinoma
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.
Study Overview
Detailed Description
OBJECTIVES: I. Evaluate the response rate to dolastatin 10 in patients with advanced renal cell carcinoma. II. Describe the toxicities of this regimen in this patient population. III. Assess the development of peripheral neuropathy in this patient population using this regimen. IV. Assess a limited sampling of pharmacokinetics and correlate with toxicity in these patients.
OUTLINE: Patients receive dolastatin 10 IV every 3 weeks. Treatment continues for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients with documented complete response receive an additional 2 courses, and may receive retreatment at the time of progression at the discretion of the investigator. Patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 4-15 months.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85259
- Mayo Clinic Scottsdale
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic Jacksonville
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Henry C. Pitot, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Dolastatin 10
Other Study ID Numbers
- CDR0000067094
- P30CA015083 (U.S. NIH Grant/Contract)
- 975002 (Other Identifier: Mayo Clinic Cancer Center)
- T98-0024 (Other Identifier: NCI Protocol)
- 372-99 (Other Identifier: Mayo Clinic IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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