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Decitabine in Treating Patients With Advanced Solid Tumors

This study has been completed.
Study NCT00030615.   Last updated on September 22, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Decitabine in Treating Patients With Advanced Solid Tumors
Official Title  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

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.

Detailed Description

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.

Study Phase Phase I
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Bladder Cancer
Breast Cancer
Melanoma (Skin)
Unspecified Adult Solid Tumor, Protocol Specific
Intervention  Drug: decitabine
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  24
Start Date  February 2002
Completion Date
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00030615
Organization ID CDR0000069182
Secondary IDs †† LAC-USC-0C0101, NCI-5353
Study Sponsor  Norris Comprehensive Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Ana Aparicio, MD     Norris Comprehensive Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date March 2006
First Received Date  February 14, 2002
Last Updated Date September 22, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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