NCT00003914

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 1999

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

April 27, 2004

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 11, 2011

Status Verified

May 1, 2011

Enrollment Period

3 years

First QC Date

November 1, 1999

Last Update Submit

May 10, 2011

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancerrecurrent renal cell cancer

Interventions

dolastatin 10DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

dolastatin 10

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Henry C. Pitot, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 27, 2004

Study Start

August 1, 1999

Primary Completion

August 1, 2002

Study Completion

May 1, 2009

Last Updated

May 11, 2011

Record last verified: 2011-05

Locations

US(3)