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
18 Years
N/A
Both
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
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria
Outcome Time Frame:
6 weeks
Safety Issue:
Yes
Principal Investigator
Jeffrey Weber
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Southern California
Authority:
United States: Food and Drug Administration
Study ID:
NCI-2012-02727
NCT ID:
NCT00030615
Start Date:
December 2001
Completion Date:
Related Keywords:
- 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
- Urinary Bladder Neoplasms
- Breast Neoplasms
- Melanoma
- Breast Neoplasms, Male
Name | Location |
|---|---|
| University of Southern California | Los Angeles, California 90033 |
