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Decitabine in Treating Patients With Advanced Solid Tumors

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.
 
ClinicalTrials.gov Identifier: NCT00030615
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE February 14, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date February 7, 2013
Study Start Date  ICMJE December 2001
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Decitabine in Treating Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase I Study Of The Toxicities, Biologic And Clinical Effects Of Daily 5 Aza 2'Deoxycytidine (DAC), NSC 127716 (IND 50733) For Four Weeks In Patients With Advanced Malignancies
Brief Summary This phase I trial is studying the side effects and best dose of decitabine in treating patients with advanced solid tumors that have not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors.

II. Determine the toxic effects of this drug in these patients. III. Determine the dose of this drug with biologic activity in these patients. IV. Determine the pharmacokinetics of this drug in these patients. V. Determine clinical response to this drug in these patients.

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

Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of decitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 2 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Male Breast Cancer
  • Recurrent Bladder Cancer
  • Recurrent Breast Cancer
  • Recurrent Melanoma
  • Stage III Melanoma
  • Stage IV Bladder Cancer
  • Stage IV Breast Cancer
  • Stage IV Melanoma
  • Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Drug: decitabine
    Given IV
    Other Names:
    • 5-aza-dCyd
    • 5AZA
    • DAC
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (decitabine)

Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of decitabine until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Interventions:
  • Drug: decitabine
  • Other: pharmacological study
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2007)
24
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of advanced metastatic solid tumor for which all standard therapy has failed, including, but not limited to the following:

    • Stage III or IV melanoma

      • Mucosal melanoma allowed
      • No resectable stage III melanoma
    • Bladder cancer
    • Breast cancer
  • No active symptomatic CNS disease
  • No radiographically evident cerebral edema
  • Hormone receptor status:

    • Not specified
  • Male or female
  • Performance status - ECOG 0-1
  • Hemoglobin at least 9.0 g/dL
  • Platelet count at least 100,000/mm^3
  • WBC at least 3,500/mm^3
  • Absolute granulocyte count at least 1,500/mm^3
  • No coagulation disorders
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT less than 2.5 times ULN
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative
  • Creatinine no greater than 1.5 times ULN
  • No major cardiovascular system illness
  • No major respiratory system illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No major systemic infection
  • At least 1 month since prior radiotherapy
  • At least 1 month since any prior anticancer therapy or adjuvant therapy
  • No other experimental treatment within 30 days prior to, during, and for 30 days after study therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00030615
Other Study ID Numbers  ICMJE NCI-2012-02727
OC-01-01
U01CA062505 ( U.S. NIH Grant/Contract )
CDR0000069182 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Weber University of Southern California
PRS Account National Cancer Institute (NCI)
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP