Dolastatin 10 in Treating Patients With Advanced Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003914
Recruitment Status : Completed
First Posted : April 27, 2004
Last Update Posted : May 11, 2011
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

November 1, 1999
April 27, 2004
May 11, 2011
August 1999
August 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003914 on Archive Site
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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.

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.

Phase 2
Primary Purpose: Treatment
Kidney Cancer
Drug: dolastatin 10
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2009
August 2002   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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 )
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Henry C. Pitot, M.D., Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Henry C. Pitot, MD Mayo Clinic
Mayo Clinic
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP