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6-Hydroxymethylacylfulvene in Treating Patients With Metastatic Kidney Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003390
  Purpose

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 6-hydroxymethylacylfulvene in treating patients with metastatic kidney cancer.


Condition Intervention Phase
Kidney Cancer
Drug: irofulven
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Trial of 6-Hydroxymethylacylfulvene (MGI-114) in Patients With Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1998
Detailed Description:

OBJECTIVES: I. Evaluate the efficacy of 6-hydroxymethylacylfulvene (HMAF) in patients with metastatic renal cell carcinoma. II. Investigate the safety of HMAF given to this patient population.

OUTLINE: Patients receive 6-hydroxymethylacylfulvene intravenously for 5 minutes every day for 5 consecutive days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed after every 2 treatment courses.

PROJECTED ACCRUAL: Approximately 12-37 patients will be accrued for this study within 6-19 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma and evidence of metastatic disease Bidimensionally measurable disease No active brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin within normal range ALT/AST no greater than 2.5 times upper limit of normal (ULN) Renal: Creatinine within 1.5 times ULN AND Creatinine clearance at least 50 mL/min Other: Not pregnant or lactating Fertile patients must use effective contraception No prior malignancy within 5 years and at low risk for recurrence Must have undergone potentially curative therapy for prior malignancy

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since biological therapy and recovered Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since hormone therapy and recovered Radiotherapy: At least 4 weeks since radiotherapy Surgery: At least 4 weeks since major surgery

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003390

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: William Berg, MD Sanofi-Aventis
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066388, MSKCC-98009, MSKCC-98007, NCI-T97-0119
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003390     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Urinary Tract Neoplasm
Kidney Cancer
Urogenital Neoplasms
Urologic Neoplasms
Recurrence
Carcinoma
Renal Cancer
Radiation-Sensitizing Agents
Urologic Diseases
Kidney Neoplasms
Irofulven
Carcinoma, Renal Cell
Antineoplastic Agents, Alkylating
Kidney Diseases
Adenocarcinoma
Alkylating Agents
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Carcinoma, Renal Cell
Irofulven
Antineoplastic Agents, Alkylating
Kidney Diseases
Adenocarcinoma
Alkylating Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 01, 2009