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Completed

NCT Number: NCT00030615

Decitabine in Treating Patients With Advanced Solid Tumors

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

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Key information

Conditions

Male Breast Cancer Breast Diseases Breast Neoplasms Breast Neoplasms, Male Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Recurrent Bladder Cancer Recurrent Breast Cancer Recurrent Melanoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stage III Melanoma Stage IV Bladder Cancer Stage IV Breast Cancer Stage IV Melanoma Unspecified Adult Solid Tumor, Protocol Specific Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Southern California

Los Angeles, California, 90033-0804, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

decitabine

Drug

Given IV

Other names: 5-aza-dCyd, 5AZA, DAC

pharmacological study

Other

Correlative studies

Other names: pharmacological studies

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

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

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2008
First posted
Jan 27, 2003
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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