Decitabine in Treating Patients With Advanced Solid Tumors

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00030615

Collaborator

(none)

Enrollment

Location

Arm

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
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	Drug: decitabine Other: pharmacological study Other: laboratory biomarker analysis	Phase 1

Detailed Description

PRIMARY OBJECTIVES:

Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Dec 1, 2001

Actual Primary Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (decitabine) 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.	Drug: decitabine Given IV Other Names: 5-aza-dCyd 5AZA DAC Other: pharmacological study Correlative studies Other Names: pharmacological studies Other: laboratory biomarker analysis Correlative studies

Arm

Intervention/Treatment

Experimental: Treatment (decitabine)

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.

Drug: decitabine

Given IV

Other Names:

5-aza-dCyd

5AZA

DAC

Other: pharmacological study

Correlative studies

Other Names:

pharmacological studies

Other: laboratory biomarker analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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