Clinical trial NCT00030615: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Jeffrey Weber
role: PRINCIPAL_INVESTIGATOR
References: