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Pyroxamide in Treating Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT00042900
Recruitment Status : Completed
First Posted : July 8, 2003
Last Update Posted : June 5, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer.


Condition or disease Intervention/treatment Phase
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous Condition Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific Drug: pyroxamide Phase 1

Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of pyroxamide in patients with advanced malignancies.
  • Define, qualitatively and quantitatively, the dose-limiting and non-dose-limiting toxic effects of this drug in these patients.
  • Describe the pharmacologic behavior of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive pyroxamide IV continuously over 5-7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of pyroxamide 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 monthly for resolution of adverse events.

PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study.


Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies
Study Start Date : April 2002
Actual Primary Completion Date : September 2002
Actual Study Completion Date : September 2002

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Lymphosarcoma Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic B-cell Lymphoma Diffuse Large B-Cell Lymphoma Multiple Myeloma Myelofibrosis Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Small Intestine Cancer Polycythemia Vera Essential Thrombocythemia Monoclonal Gammopathy of Undetermined Significance Lymphoma, Large-cell Hodgkin Lymphoma Anaplastic Large Cell Lymphoma Mantle Cell Lymphoma Chronic Myeloid Leukemia Chronic Myeloproliferative Disorders Follicular Lymphoma Cutaneous T-cell Lymphoma AL Amyloidosis Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Marginal Zone Lymphoma Mycosis Fungoides Sezary Syndrome Waldenstrom Macroglobulinemia Burkitt Lymphoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Aggressive NK Cell Leukemia Leukemia, T-cell, Chronic Hairy Cell Leukemia Primary Central Nervous System Lymphoma Plasmacytoma Adult T-cell Leukemia/lymphoma Large Granular Lymphocyte Leukemia Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor or hematologic malignancy

    • Disease that has failed standard therapies (e.g., surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no curative or life- prolonging therapy is available

  • Measurable or clinically evaluable disease

    • Elevated tumor marker is acceptable for evaluable disease
  • No known carcinomatous meningitis, primary brain tumors, or metastatic brain disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 125,000/mm^3
  • Hemoglobin at least 9.0 g/dL

Hepatic

  • Bilirubin normal
  • AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • PT no greater than 1.5 times ULN

Renal

  • Creatinine normal

Other

  • HIV-positive status allowed
  • Prior malignancy allowed
  • No severe physical or emotional illness that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent bone marrow growth factors

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior wide-field radiotherapy and recovered
  • At least 2 weeks since prior limited-field radiotherapy and recovered
  • Recovered from prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • No other concurrent antitumor treatment
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042900


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Chair: Leonard B. Saltz, MD Memorial Sloan Kettering Cancer Center
More Information
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ClinicalTrials.gov Identifier: NCT00042900     History of Changes
Other Study ID Numbers: 99-090
CDR0000069483 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2110
First Posted: July 8, 2003    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
AIDS-related peripheral/systemic lymphoma
AIDS-related primary CNS lymphoma
T-cell large granular lymphocyte leukemia
Waldenström macroglobulinemia
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
primary myelofibrosis
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
 essential thrombocythemia
extramedullary plasmacytoma
intraocular lymphoma
isolated plasmacytoma of bone
meningeal chronic myelogenous leukemia
monoclonal gammopathy of undetermined significance
polycythemia vera
previously treated myelodysplastic syndromes
primary central nervous system non-Hodgkin lymphoma
primary systemic amyloidosis
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult Hodgkin lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent adult acute lymphoblastic leukemia

Additional relevant MeSH terms:
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Lymphoma
Syndrome
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Plasmacytoma
Myeloproliferative Disorders
Precancerous Conditions
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site