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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Thomas Keane, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Winship Cancer Institute of Emory University

Authority:

United States: Federal Government

Study ID:

CDR0000066608

NCT ID:

NCT00003551

Start Date:

August 1998

Completion Date:

September 2004

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Emory University Hospital - AtlantaAtlanta, Georgia  30322
Emory University School of MedicineAtlanta, Georgia  30322