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KRN5500 in Treating Patients With Solid Tumors
This study is ongoing, but not recruiting participants.
First Received: June 6, 2001   Last Updated: 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: 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

Study ID Numbers: CDR0000068666, DFCI-00102, NCI-1653
Study First Received: June 6, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00017238     History of Changes
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 November 27, 2009