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KRN5500 in Treating Patients With Solid Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2004 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on June 6, 2001.   Last Updated on July 23, 2008   History of Changes
Sponsor: Dana-Farber Cancer Institute
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00017238
  Purpose

RATIONALE: Drugs used in chemotherapy, such as KRN5500, work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of KRN5500 in treating patients who have solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: KRN5500
Phase I

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial Of KRN5500 (NSC 650426) Given As 72 Hour Continuous IV Infusion Every 21 Days In Patients With Solid Tumors

Resource links provided by NLM:


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

Study Start Date: June 2001
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose and dose-limiting toxic effects of KRN5500 in patients with solid tumors.
  • Assess the safety of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the response, by 3'deoxy- 3'fluorothymidine positron emission tomography scan, of a subset of patients treated with this drug.

Secondary

  • Determine, preliminarily, the antitumor activity of this drug in these patients.
  • Determine pharmacodynamic relationships for the pharmacological effect of this drug upon surrogate markers of activity and toxicity in these patients.
  • Compare the toxicity profiles for the 1-hour and 72-hour infusion administration schedules of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive KRN5500 IV over 24-72 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-3 patients receive KRN5500 at the starting dose over escalating infusion durations. After the longest duration of infusion time is safely reached, cohorts of 3-6 patients receive escalating doses of KRN5500 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with KRN5500 at the recommended phase II dose.

Patients are followed every 4 weeks until resolution of all toxicity.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Metastatic or inoperable malignancy for which there is no known curative or survival-prolonging palliative therapy or that has failed all such therapies

    • No leukemia or primary CNS tumors
  • No active brain metastases, including:

    • No evidence of cerebral edema by CT scan or MRI
    • No progression from prior imaging study
    • No requirement for steroids
    • No related clinical symptoms

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT and SGPT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No uncontrolled or significant cardiac disease
  • No myocardial infarction within the past 6 months
  • No significant congestive heart failure
  • No prior clinically significant atrial or ventricular arrhythmia
  • No prior second- or third-degree heart block
  • No evidence of acute ischemia or prolonged QTc interval (greater than 450 ms) on electrocardiogram

Pulmonary:

  • No uncontrolled or significant pulmonary disease

Other:

  • No serious uncontrolled medical disorder that would preclude study participation
  • No active infection
  • No psychiatric illness that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy

Surgery:

  • At least 2 weeks since prior major surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017238

Locations
United States, Louisiana
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States, 71130-3932
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Study Chair: Joseph Paul Eder, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00017238     History of Changes
Other Study ID Numbers: CDR0000068666, DFCI-00102, NCI-1653
Study First Received: June 6, 2001
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on February 12, 2012