Decitabine in Treating Patients With Advanced Solid Tumors
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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. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
| Condition | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 24 |
| Study Start Date: | December 2001 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| University of Southern California | |
| Los Angeles, California, United States, 90033-0804 | |
| Principal Investigator: | Jeffrey Weber | University of Southern California |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030615 History of Changes |
| Other Study ID Numbers: | NCI-2012-02727, OC-01-01, U01CA062505, CDR0000069182 |
| Study First Received: | February 14, 2002 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms, Male Urinary Bladder Neoplasms Breast Neoplasms Melanoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Breast Diseases Skin Diseases Neuroendocrine Tumors |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Decitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013