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Decitabine in Treating Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00030615   Information provided by National Cancer Institute (NCI)
First Received: February 14, 2002   Last Updated: January 10, 2009   History of Changes

February 14, 2002
January 10, 2009
February 2002
September 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00030615 on ClinicalTrials.gov Archive Site
 
 
 
Decitabine in Treating Patients With Advanced Solid Tumors
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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: 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.

OBJECTIVES:

  • Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors.
  • Determine the toxic effects of this drug in these patients.
  • Determine the dose of this drug with biologic activity in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • 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.

PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study.

Phase I
Interventional
Treatment
  • Bladder Cancer
  • Breast Cancer
  • Melanoma (Skin)
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: decitabine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
24
 
September 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • 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

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No major cardiovascular system illness

Pulmonary:

  • No major respiratory system illness

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No major systemic infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 1 month since prior radiotherapy

Surgery:

  • Not specified

Other:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00030615
 
CDR0000069182, LAC-USC-0C0101, NCI-5353
USC/Norris Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Ana Aparicio, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
March 2006

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