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Pyroxamide in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00042900
First received: August 5, 2002
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies

Resource links provided by NLM:

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

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: April 2002
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042900

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Leonard B. Saltz, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00042900     History of Changes
Other Study ID Numbers: 99-090, CDR0000069483, NCI-2110
Study First Received: August 5, 2002
Last Updated: June 4, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 20, 2014