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Decitabine in Treating Patients With Advanced Solid Tumors

Primary Purpose

Male Breast Cancer, Recurrent Bladder Cancer, Recurrent Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
decitabine
pharmacological study
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (decitabine)

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
February 6, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00030615
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (decitabine)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
decitabine
Other Intervention Name(s)
5-aza-dCyd, 5AZA, DAC
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
pharmacological study
Other Intervention Name(s)
pharmacological studies
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Weber
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States

12. IPD Sharing Statement

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Decitabine in Treating Patients With Advanced Solid Tumors

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