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A Phase I Study of the Biologic and Clinical Effects of 5-AZA-2'Deoxycytidine (DAC) in Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous Condition, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of the Biologic and Clinical Effects of 5-AZA-2'Deoxycytidine (DAC) in Patients With Advanced Malignancies


OBJECTIVES: I. Identify dosage level(s) of decitabine (DAC) that show biologic activity and
acceptable side effects. II. Describe the side effects and toxicity of DAC at the doses
studied. III. Determine the steady state DAC serum levels at the doses studied. IV. Document
any clinical responses to DAC.

OUTLINE: A dose escalation schedule for the administration of decitabine (DAC) is being used
to determine the MTD and biologically active dose. Patients are given two 12 hour continuous
infusions per day, for 3 days at each dose level. A minimum of 3 patients are enrolled at
each dose level until dose limiting toxicity (DLT) or biologic activity is observed. If DLT
or biologic activity is observed at a particular dose level, an additional 3 patients are
enrolled, for a total of 6. If 2 or more patients experience DLT, dose escalation is ceased.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Stage III (nonresectable) and IV melanoma, or any other advanced
metastatic malignancy for which all standard therapy has failed Must have at least two
cutaneous, mucosal or lymph nodal lesions that can be biopsied or one lesion large enough
to be biopsied twice

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: Hemoglobin at least 9.0 g/dL Platelet count at least
100,000/mm3 WBC at least 3500/mm3 Absolute granulocyte count at least 1500/mm3 Hepatic:
Bilirubin no greater than 1.5 mg/dL SGOT and SGPT less than 2.5 times normal Renal:
Creatinine no greater than 1.8 mg/dL Other: Not pregnant Not HIV or hepatitis BsAg
positive No major systemic infections No coagulation disorders No major illness of
cardiovascular or respiratory systems No symptomatic CNS disease or evidence of cerebral
edema

PRIOR CONCURRENT THERAPY: No therapy for cancer within the past month

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jeffrey S. Weber, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065502

NCT ID:

NCT00002980

Start Date:

May 1997

Completion Date:

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Precancerous Condition
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage IV adult Hodgkin lymphoma
  • monoclonal gammopathy of undetermined significance
  • recurrent adult Hodgkin lymphoma
  • isolated plasmacytoma of bone
  • extramedullary plasmacytoma
  • refractory multiple myeloma
  • Waldenström macroglobulinemia
  • stage IV chronic lymphocytic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • unspecified adult solid tumor, protocol specific
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • polycythemia vera
  • primary myelofibrosis
  • essential thrombocythemia
  • untreated hairy cell leukemia
  • progressive hairy cell leukemia, initial treatment
  • refractory hairy cell leukemia
  • chronic myelomonocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • acute undifferentiated leukemia
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • secondary acute myeloid leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • prolymphocytic leukemia
  • primary systemic amyloidosis
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Beckman Research Institute, City of HopeLos Angeles, California  91010
University of California Davis Cancer CenterSacramento, California  95817
Los Angeles County-University of Southern California Medical CenterLos Angeles, California  90033