Aminocamptothecin in Treating Patients With Advanced or Recurrent 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: NCT00003551
Recruitment Status : Completed
First Posted : September 13, 2004
Last Update Posted : June 21, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: aminocamptothecin colloidal dispersion Phase 2

Detailed Description:

OBJECTIVES: I. Determine the response rate, duration of response, and survival of patients with advanced renal cell carcinoma treated with aminocamptothecin colloidal dispersion. II. Determine the nature and degree of toxicity of aminocamptothecin in this patient population.

OUTLINE: Patients receive aminocamptothecin colloidal dispersion intravenously for 120 hours weekly for 2 weeks followed by 1 week of rest. Courses are repeated every 3 weeks in the absence of disease progression or dose limiting toxicity. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and yearly thereafter.

PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 2 years.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of 9-Amino-20(S)-Camptothecin (9-AC) (NSC 603071) and Evaluation of Drug Resistance in Patients With Advanced Renal Cell Carcinoma
Study Start Date : August 1998
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003551

United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Cancer Institute (NCI)
Study Chair: Thomas Keane, MD Emory University Identifier: NCT00003551     History of Changes
Other Study ID Numbers: CDR0000066608
First Posted: September 13, 2004    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: July 2000

Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type