NCT00003551

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 aminocamptothecin in treating patients with stage III, stage IV, or recurrent kidney cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 1998

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 13, 2004

Completed
Last Updated

June 21, 2013

Status Verified

July 1, 2000

First QC Date

November 1, 1999

Last Update Submit

June 20, 2013

Conditions

Kidney Cancer

Keywords

stage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancer

Interventions

aminocamptothecin colloidal dispersionDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven stage III, stage IV, or recurrent renal cell carcinoma Measurable disease No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 1500/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL ALT and AST no greater than 2.5 times the institutional normal values Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled systemic infection No other prior or concurrent malignancies except nonmelanoma skin cancer, carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast that have been curatively treated No evidence of delirium, confusion, suicidal ideation, or untreated depression PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior cytokines and recovered No more than 1 prior treatment with cytokines (interleukin-2 or interferons) Chemotherapy: No prior cytotoxic chemotherapy No prior aminocamptothecin No other concurrent antineoplastic agents Endocrine therapy: At least 30 days since prior hormone therapy and recovered No more than 1 prior hormone therapy (tamoxifen or medroxyprogesterone) Radiotherapy: Prior radiotherapy allowed if indicator lesion and greater than 15% of marrow producing bone have not been irradiated Surgery: Recovered from prior surgery Other: At least 30 days since other investigational agents No concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (2)

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

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

  • Thomas Keane, MD

    Emory University

    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

September 13, 2004

Study Start

August 1, 1998

Study Completion

September 1, 2004

Last Updated

June 21, 2013

Record last verified: 2000-07

Locations

US(2)